FDA device recalls
Every device recall FDA opened in the last 12 months.
FDA opened 2,781 medical-device recalls in the twelve months to , out of 58,909 on record since 1976. Recall class comes from FDA's enforcement reports: Class I means a reasonable probability of serious injury or death, Class II a temporary or reversible problem, Class III unlikely to cause harm.
Retrieved · ingest status · methodology
Showing the 250 most recent of 2,781. This page lists at most 250 — for a complete set of a code's recalls, open that code's page or export it.
| Initiated | Class | Code | Recalling firm | Reason | Status |
|---|---|---|---|---|---|
| Z-2877-2026 | Recall, class not published | None | Biofire Defense | Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test. | Open, Classified |
| Z-2878-2026 | Recall, class not published | MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies Incresolved: GE Medical Systems Information Technologies, Inc. | Portrait Core Services Software version V1.2.0 Security Vulnerability | Open, Classified |
| Z-2761-2026 | Class II recall | GCJLaparoscope, General & Plastic Surgery | Olympus Corporation of the Americas | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. | Open, Classified |
| Z-2836-2026 | Recall, class not published | CAEAirway, Oropharyngeal, Anesthesiology | INTEGRATED MEDCRAFT LLC | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Open, Classified |
| Z-2837-2026 | Recall, class not published | OHOFirst Aid Kit Without Drug | INTEGRATED MEDCRAFT LLC | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Open, Classified |
| Z-2890-2026 | Recall, class not published | JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Siemens Healthcare Diagnostics, Inc. | processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. | Open, Classified |
| Z-2820-2026 | Recall, class not published | MQVFiller, Bone Void, Calcium Compound | IsoTis OrthoBiologics, Inc. | Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth. | Open, Classified |
| Z-2827-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2828-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2829-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2830-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2831-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2832-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2833-2026 | Recall, class not published | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker GmbHresolved: Stryker Corporation | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Open, Classified |
| Z-2867-2026 | Recall, class not published | LXHOrthopedic Manual Surgical Instrument | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Open, Classified |
| Z-2868-2026 | Recall, class not published | LXHOrthopedic Manual Surgical Instrument | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Open, Classified |
| Z-2869-2026 | Recall, class not published | LXHOrthopedic Manual Surgical Instrument | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Open, Classified |
| Z-2870-2026 | Recall, class not published | LXHOrthopedic Manual Surgical Instrument | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Open, Classified |
| Z-2871-2026 | Recall, class not published | LXHOrthopedic Manual Surgical Instrument | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Open, Classified |
| Z-2894-2026 | Recall, class not published | JITCalibrator, Secondary | Aniara Diagnostica LLC | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. | Open, Classified |
| Z-2895-2026 | Recall, class not published | JIXCalibrator, Multi-Analyte Mixture | Aniara Diagnostica LLC | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. | Open, Classified |
| Z-2896-2026 | Recall, class not published | GGNPlasma, Coagulation Control | Aniara Diagnostica LLC | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. | Open, Classified |
| Z-2725-2026 | Class II recall | KYZSyringe, Irrigating (Non Dental) | Boston Scientific Corporation | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure. | Open, Classified |
| Z-2775-2026 | Class II recall | QJFAutofluorescence Imaging Adjunct Tool For Wounds | KENT IMAGING, INC. | The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected. | Open, Classified |
| Z-2838-2026 | Recall, class not published | FCLForceps, Biopsy, Non-Electric | Boston Scientific Corporation | Potential for breach in sterile barrier of device packaging. | Open, Classified |
| Z-2839-2026 | Recall, class not published | FCLForceps, Biopsy, Non-Electric | Boston Scientific Corporation | Potential for breach in sterile barrier of device packaging. | Open, Classified |
| Z-2840-2026 | Recall, class not published | FCLForceps, Biopsy, Non-Electric | Boston Scientific Corporation | Potential for breach in sterile barrier of device packaging. | Open, Classified |
| Z-2874-2026 | Recall, class not published | LLZSystem, Image Processing, Radiological | Merge Healthcare, Inc.resolved: Merge Healthcare Incorporated | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. | Open, Classified |
| Z-2875-2026 | Recall, class not published | LLZSystem, Image Processing, Radiological | Merge Healthcare, Inc.resolved: Merge Healthcare Incorporated | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. | Open, Classified |
| Z-2876-2026 | Recall, class not published | DPSElectrocardiograph | GE Medical Systems Information Technologies Incresolved: GE Medical Systems Information Technologies, Inc. | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient. | Open, Classified |
| Z-2880-2026 | Recall, class not published | KLREnzyme Immunoassay, Lidocaine | Siemens Healthcare Diagnostics, Inc. | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated. | Open, Classified |
| Z-2881-2026 | Recall, class not published | LFGRadioimmunoassay, Tricyclic Antidepressant Drugs | Siemens Healthcare Diagnostics, Inc. | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated. | Open, Classified |
| Z-2888-2026 | Recall, class not published | LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Beckman Coulter Inc.resolved: Beckman Coulter, Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." | Open, Classified |
| Z-2889-2026 | Recall, class not published | LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Beckman Coulter Inc.resolved: Beckman Coulter, Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." | Open, Classified |
| Z-2735-2026 | Recall, class not published | CBKVentilator, Continuous, Facility Use | ResMed Ltd.resolved: Resmed Corporation | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy. | Open, Classified |
| Z-2841-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2842-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2843-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2844-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2845-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2846-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2847-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2848-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2849-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2850-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2851-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2852-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2853-2026 | Recall, class not published | ITIWheelchair, Powered | Pride Mobility Products Corp. | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode. | Open, Classified |
| Z-2759-2026 | Class II recall | LGZWarmer, Thermal, Infusion Fluid | ICU Medical Inc.resolved: ICU Medical, Inc. | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. | Open, Classified |
| Z-2806-2026 | Recall, class not published | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Open, Classified |
| Z-2807-2026 | Recall, class not published | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Open, Classified |
| Z-2808-2026 | Recall, class not published | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Open, Classified |
| Z-2809-2026 | Recall, class not published | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Open, Classified |
| Z-2810-2026 | Recall, class not published | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Open, Classified |
| Z-2811-2026 | Recall, class not published | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Open, Classified |
| Z-2860-2026 | Recall, class not published | BSZGas-Machine, Anesthesia | Maquet Critical Care AB | Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness. | Open, Classified |
| Z-2835-2026 | Recall, class not published | ISAMassager, Therapeutic, Electric | Therabody, Incresolved: Therabody, Inc. | Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating. | Open, Classified |
| Z-2760-2026 | Class II recall | FPOStretcher, Wheeled | Ferno-Washington Inc | Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility. | Open, Classified |
| Z-2771-2026 | Class II recall | LLZSystem, Image Processing, Radiological | Boston Scientific Corporation | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation. | Open, Classified |
| Z-2856-2026 | Recall, class not published | KNNComponents, Wheelchair | MUNEVO GMBH | A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders. | Open, Classified |
| Z-2758-2026 | Class II recall | HXIPasser, Wire, Orthopedic | Paragon 28, Inc. | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. | Open, Classified |
| Z-2768-2026 | Class II recall | HBGDrills, Burrs, Trephines & Accessories (Manual) | Medtronic Neurosurgery | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process. | Open, Classified |
| Z-2812-2026 | Recall, class not published | OFTSpinal Epidural Anesthesia Kit | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2813-2026 | Recall, class not published | OGEEpidural Anesthesia Kit | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2814-2026 | Recall, class not published | OGJNerve Block Tray | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2815-2026 | Recall, class not published | OEQAngiography/Angioplasty Kit | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2816-2026 | Recall, class not published | OESCardiac Catheterization Kit | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2817-2026 | Recall, class not published | OJGNeurological Tray | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2818-2026 | Recall, class not published | LROGeneral Surgery Tray | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2819-2026 | Recall, class not published | OKEPort Introducer Kit | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. | Open, Classified |
| Z-2879-2026 | Recall, class not published | LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief | Boston Scientific Neuromodulation Corporation | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. | Open, Classified |
| Z-2891-2026 | Recall, class not published | OWBInterventional Fluoroscopic X-Ray System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.resolved: Philips Medical Systems Nederland B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | Open, Classified |
| Z-2892-2026 | Recall, class not published | OWBInterventional Fluoroscopic X-Ray System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.resolved: Philips Medical Systems Nederland B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | Open, Classified |
| Z-2893-2026 | Recall, class not published | OWBInterventional Fluoroscopic X-Ray System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.resolved: Philips Medical Systems Nederland B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | Open, Classified |
| Z-2640-2026 | Class II recall | IYEAccelerator, Linear, Medical | Accuray Incorporated | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. | Open, Classified |
| Z-2644-2026 | Class II recall | IYEAccelerator, Linear, Medical | Accuray Incorporated | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. | Open, Classified |
| Z-2776-2026 | Class II recall | HIFInsufflator, Laparoscopic | Olympus Corporation of the Americas | Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. | Open, Classified |
| Z-2778-2026 | Class II recall | NDCCalculator, Drug Dose | Medtronic MiniMed, Inc.resolved: Medtronic Minimed | For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia. | Open, Classified |
| Z-2854-2026 | Recall, class not published | JQPCalculator/Data Processing Module, For Clinical Use | Copan WASP | Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. | Open, Classified |
| Z-2803-2026 | Recall, class not published | LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Argon Medical Devices, Inc | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection. | Open, Classified |
| Z-2804-2026 | Recall, class not published | LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Argon Medical Devices, Inc | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection. | Open, Classified |
| Z-2746-2026 | Class II recall | CDZRadioimmunoassay, Testosterones And Dihydrotestosterone | Tosoh Bioscience Incresolved: Tosoh Bioscience, Inc. | The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures. | Open, Classified |
| Z-2650-2026 | Recall, class not published | JAKSystem, X-Ray, Tomography, Computed | PHILIPS MEDICAL SYSTEMSresolved: Philips Medical Systems, Inc. | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. | Open, Classified |
| Z-2651-2026 | Recall, class not published | JAKSystem, X-Ray, Tomography, Computed | PHILIPS MEDICAL SYSTEMSresolved: Philips Medical Systems, Inc. | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. | Open, Classified |
| Z-2652-2026 | Recall, class not published | JAKSystem, X-Ray, Tomography, Computed | PHILIPS MEDICAL SYSTEMSresolved: Philips Medical Systems, Inc. | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. | Open, Classified |
| Z-2681-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2682-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2683-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2684-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2685-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2686-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2687-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2688-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2689-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2690-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2691-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2692-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2693-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Open, Classified |
| Z-2750-2026 | Class II recall | QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. | Open, Classified |
| Z-2751-2026 | Class II recall | QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. | Open, Classified |
| Z-2752-2026 | Class II recall | QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. | Open, Classified |
| Z-2753-2026 | Class II recall | QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Boston Scientific Corporation | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. | Open, Classified |
| Z-2754-2026 | Class II recall | DRACatheter, Steerable | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. | Open, Classified |
| Z-2755-2026 | Class II recall | DRACatheter, Steerable | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. | Open, Classified |
| Z-2756-2026 | Class II recall | DRACatheter, Steerable | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. | Open, Classified |
| Z-2757-2026 | Class II recall | DRACatheter, Steerable | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. | Open, Classified |
| Z-2788-2026 | Class II recall | OEZCardiovascular Procedure Kit | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. | Open, Classified |
| Z-2789-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. | Open, Classified |
| Z-2790-2026 | Class II recall | OJGNeurological Tray | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. | Open, Classified |
| Z-2791-2026 | Class II recall | OJHOrthopedic Tray | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. | Open, Classified |
| Z-2857-2026 | Recall, class not published | OWBInterventional Fluoroscopic X-Ray System | Oxos Medical Incresolved: Oxos Medical, Inc. | Due to a defective circuit board that overheats | Open, Classified |
| Z-2678-2026 | Class I recall | DYBIntroducer, Catheter | Oscor Inc.resolved: Oscor, Inc. | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Open, Classified |
| Z-2679-2026 | Class I recall | DYBIntroducer, Catheter | Oscor Inc.resolved: Oscor, Inc. | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Open, Classified |
| Z-2680-2026 | Class I recall | DYBIntroducer, Catheter | Oscor Inc.resolved: Oscor, Inc. | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Open, Classified |
| Z-2723-2026 | Class II recall | FRNPump, Infusion | ICU Medical, Inc. | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | Open, Classified |
| Z-2724-2026 | Class II recall | FRNPump, Infusion | ICU Medical, Inc. | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | Open, Classified |
| Z-2729-2026 | Class II recall | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthofix U.S. LLC | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Open, Classified |
| Z-2730-2026 | Class II recall | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthofix U.S. LLC | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Open, Classified |
| Z-2731-2026 | Class II recall | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthofix U.S. LLC | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Open, Classified |
| Z-2732-2026 | Class II recall | KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthofix U.S. LLC | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | Open, Classified |
| Z-2736-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device. | Open, Classified |
| Z-2737-2026 | Class II recall | OJHOrthopedic Tray | Medline Industries, LP | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device. | Open, Classified |
| Z-2673-2026 | Class II recall | KCYTourniquet, Pneumatic | Zimmer Surgical Inc | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. | Open, Classified |
| Z-2674-2026 | Class II recall | KCYTourniquet, Pneumatic | Zimmer Surgical Inc | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. | Open, Classified |
| Z-2717-2026 | Class II recall | SCVModular Electromechanical Surgical System | CMR SURGICAL LIMITED | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. | Open, Classified |
| Z-2648-2026 | Class II recall | OWBInterventional Fluoroscopic X-Ray System | Siemens Medical Solutions USA, Incresolved: Siemens Medical Solutions USA, Inc. | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. | Open, Classified |
| Z-2677-2026 | Class II recall | FRODressing, Wound, Drug | ConvaTec, Incresolved: Convatec Inc. | Surgical dressing manufactured out of specification (greater thickness). | Open, Classified |
| Z-2699-2026 | Class II recall | QJJIndirect Bonding Tray | Klowen Braces | A product error defect may cause incorrect bracket placement. | Open, Classified |
| Z-2703-2026 | Class II recall | PDJHemoglobin A1c Test System | Siemens Healthcare Diagnostics, Inc. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. | Open, Classified |
| Z-2764-2026 | Class I recall | LROGeneral Surgery Tray | Medline Industries, LP | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. | Open, Classified |
| Z-2765-2026 | Class I recall | OJHOrthopedic Tray | Medline Industries, LP | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. | Open, Classified |
| Z-2773-2026 | Class II recall | OUTIntracranial Aneurysm Flow Diverter | Micro Therapeutics, Inc.resolved: Micro Therapeutics Inc, Dba Ev3 Neurovascular | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. | Open, Classified |
| Z-2774-2026 | Class II recall | OUTIntracranial Aneurysm Flow Diverter | Micro Therapeutics, Inc.resolved: Micro Therapeutics Inc, Dba Ev3 Neurovascular | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. | Open, Classified |
| Z-2779-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2780-2026 | Class II recall | OHDGynecological Laparoscopic Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2781-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2782-2026 | Class II recall | OHDGynecological Laparoscopic Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2783-2026 | Class II recall | OHDGynecological Laparoscopic Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2784-2026 | Class II recall | OHDGynecological Laparoscopic Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2785-2026 | Class II recall | OHDGynecological Laparoscopic Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2786-2026 | Class II recall | OHDGynecological Laparoscopic Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2787-2026 | Class II recall | OKVObstetrical Kit | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. | Open, Classified |
| Z-2799-2026 | Recall, class not published | LROGeneral Surgery Tray | Windstone Medical Packaging, Inc. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Open, Classified |
| Z-2800-2026 | Recall, class not published | OGREar, Nose, And Throat Surgical Tray | Windstone Medical Packaging, Inc. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Open, Classified |
| Z-2801-2026 | Recall, class not published | OJGNeurological Tray | Windstone Medical Packaging, Inc. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Open, Classified |
| Z-2802-2026 | Recall, class not published | OJHOrthopedic Tray | Windstone Medical Packaging, Inc. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Open, Classified |
| Z-2862-2026 | Recall, class not published | GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Open, Classified |
| Z-2863-2026 | Recall, class not published | GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Open, Classified |
| Z-2864-2026 | Recall, class not published | GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Open, Classified |
| Z-2865-2026 | Recall, class not published | GEIElectrosurgical, Cutting & Coagulation & Accessories | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Open, Classified |
| Z-2866-2026 | Recall, class not published | GEIElectrosurgical, Cutting & Coagulation & Accessories | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Open, Classified |
| Z-2887-2026 | Recall, class not published | JTNSusceptibility Test Discs, Antimicrobial | Hardy Diagnostics | Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome. | Open, Classified |
| Z-2579-2026 | Class II recall | MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Philips North America Llcresolved: Philips North America LLC | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. | Open, Classified |
| Z-2645-2026 | Class II recall | FPASet, Administration, Intravascular | Medela Inc | May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication. | Open, Classified |
| Z-2676-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Olympus Corporation of the Americas | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. | Open, Classified |
| Z-2714-2026 | Class II recall | GADRetractor | Integra LifeSciences Corp. (NeuroSciences) | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. | Open, Classified |
| Z-2726-2026 | Class II recall | IZLSystem, X-Ray, Mobile | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam. | Open, Classified |
| Z-2727-2026 | Class II recall | IZLSystem, X-Ray, Mobile | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam. | Open, Classified |
| Z-2728-2026 | Class II recall | IZLSystem, X-Ray, Mobile | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam. | Open, Classified |
| Z-2747-2026 | Class I recall | LROGeneral Surgery Tray | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues. | Open, Classified |
| Z-2748-2026 | Class I recall | OHMCesarean Section Tray | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues. | Open, Classified |
| Z-2749-2026 | Class I recall | OJHOrthopedic Tray | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues. | Open, Classified |
| Z-2654-2026 | Class II recall | FPASet, Administration, Intravascular | BD SWITZERLAND SARL | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. | Open, Classified |
| Z-2715-2026 | Class II recall | LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Biomerieux Incresolved: bioMerieux, Inc. | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. | Open, Classified |
| Z-2623-2026 | Class II recall | JTYCulture Media, For Isolation Of Pathogenic Neisseria | Remel, Incresolved: Remel, Inc. | Reduced or no recovery of some strains of Neisseria gonorrhoeae. | Open, Classified |
| Z-2770-2026 | Class II recall | NRYCatheter, Thrombus Retriever | Penumbra, Inc. | Due to manufacturing issues, reperfusion catheters may fractures | Open, Classified |
| Z-2741-2026 | Class II recall | GEIElectrosurgical, Cutting & Coagulation & Accessories | Maquet Cardiovascular, LLC | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. | Open, Classified |
| Z-2649-2026 | Class II recall | JADSystem, Therapeutic, X-Ray | Carl Zeiss Meditec AGresolved: Carl Zeiss Meditec, Inc. | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. | Open, Classified |
| Z-2704-2026 | Class I recall | OEZCardiovascular Procedure Kit | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Open, Classified |
| Z-2705-2026 | Class I recall | DREDilator, Vessel, For Percutaneous Catheterization | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Open, Classified |
| Z-2706-2026 | Class I recall | KNWInstrument, Biopsy | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Open, Classified |
| Z-2707-2026 | Class I recall | KNWInstrument, Biopsy | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Open, Classified |
| Z-2708-2026 | Class I recall | GDYGauze/Sponge, Internal, X-Ray Detectable | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Open, Classified |
| Z-2709-2026 | Class I recall | KNWInstrument, Biopsy | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Open, Classified |
| Z-2463-2026 | Class I recall | BZOSet, Tubing And Support, Ventilator (W Harness) | Hamilton Medical AG | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement | Open, Classified |
| Z-2777-2026 | Class II recall | EXYUroflowmeter | Emano Metrics, Inc. | Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams. | Open, Classified |
| Z-2532-2026 | Class II recall | HRSPlate, Fixation, Bone | Acumed LLC | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | Open, Classified |
| Z-2606-2026 | Class II recall | OESCardiac Catheterization Kit | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2607-2026 | Class II recall | OEZCardiovascular Procedure Kit | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2608-2026 | Class II recall | OFFCentral Venous Catheter Tray | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2609-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2610-2026 | Class II recall | CAICircuit, Breathing (W Connector, Adaptor, Y Piece) | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2611-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2612-2026 | Class II recall | OESCardiac Catheterization Kit | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2613-2026 | Class II recall | OEZCardiovascular Procedure Kit | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Open, Classified |
| Z-2695-2026 | Class II recall | CAICircuit, Breathing (W Connector, Adaptor, Y Piece) | Medline Industries, LP | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. | Open, Classified |
| Z-2696-2026 | Class II recall | OEZCardiovascular Procedure Kit | Medline Industries, LP | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. | Open, Classified |
| Z-2697-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. | Open, Classified |
| Z-2762-2026 | Class II recall | NKBThoracolumbosacral Pedicle Screw System | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. | Open, Classified |
| Z-2400-2026 | Class II recall | MVLCord, Retraction | Inter-Med Llc | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting. | Open, Classified |
| Z-2574-2026 | Class II recall | QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated | Dexcom, Inc. | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk. | Open, Classified |
| Z-2698-2026 | Class II recall | QFGAlternate Controller Enabled Insulin Infusion Pump | Medtronic MiniMed, Inc.resolved: Medtronic Minimed | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA). | Open, Classified |
| Z-2522-2026 | Class II recall | HGMSystem, Monitoring, Perinatal | Philips North America Llcresolved: Philips North America LLC | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | Open, Classified |
| Z-2523-2026 | Class II recall | HGMSystem, Monitoring, Perinatal | Philips North America Llcresolved: Philips North America LLC | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | Open, Classified |
| Z-2738-2026 | Class II recall | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | Open, Classified |
| Z-2739-2026 | Class II recall | DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic Perfusion Systems | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | Open, Classified |
| Z-2599-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | Potential for thrombus formation during prolonged use of the introducer. | Open, Classified |
| Z-2600-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | Potential for thrombus formation during prolonged use of the introducer. | Open, Classified |
| Z-2601-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | Potential for thrombus formation during prolonged use of the introducer. | Open, Classified |
| Z-2602-2026 | Class I recall | DYBIntroducer, Catheter | Abiomed, Inc. | Potential for thrombus formation during prolonged use of the introducer. | Open, Classified |
| Z-2624-2026 | Class I recall | NPVPulmonary Valve Prosthesis Percutaneously Delivered | Medtronic Heart Valves Division | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue. | Open, Classified |
| Z-2625-2026 | Class II recall | BSKCuff, Tracheal Tube, Inflatable | Hamilton Medical AG | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user. | Open, Classified |
| Z-2859-2026 | Recall, class not published | NKBThoracolumbosacral Pedicle Screw System | Innovasis, Inc | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step. | Open, Classified |
| Z-2406-2026 | Class II recall | IYEAccelerator, Linear, Medical | Elekta, Inc.resolved: Elekta Limited | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. | Open, Classified |
| Z-2514-2026 | Class II recall | FMGStopcock, I.V. Set | BD SWITZERLAND SARL | Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable. | Open, Classified |
| Z-2533-2026 | Class II recall | CBTArterial Blood Sampling Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2534-2026 | Class II recall | OFTSpinal Epidural Anesthesia Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2535-2026 | Class II recall | OGJNerve Block Tray | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2536-2026 | Class II recall | OESCardiac Catheterization Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2537-2026 | Class II recall | OEZCardiovascular Procedure Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2538-2026 | Class II recall | OFDCatheter Introducer Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2539-2026 | Class II recall | OFGCt Biopsy Tray | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2540-2026 | Class II recall | KDDKit, Surgical Instrument, Disposable | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2541-2026 | Class II recall | LROGeneral Surgery Tray | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2542-2026 | Class II recall | LRPTray, Surgical | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2543-2026 | Class II recall | LRSI.V. Start Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2544-2026 | Class II recall | PWYLumbar Puncture Tray (Adult & Pediatric) | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2545-2026 | Class II recall | MLSLabor And Delivery Kit | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2546-2026 | Class II recall | OHGCircumcision Tray | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2547-2026 | Class II recall | OJKEye Tray | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Open, Classified |
| Z-2548-2026 | Class I recall | NHJDevice, Positive Pressure Breathing, Intermittent | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Open, Classified |
| Z-2549-2026 | Class I recall | NHJDevice, Positive Pressure Breathing, Intermittent | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Open, Classified |
| Z-2550-2026 | Class I recall | NHJDevice, Positive Pressure Breathing, Intermittent | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Open, Classified |
| Z-2551-2026 | Class I recall | NHJDevice, Positive Pressure Breathing, Intermittent | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | Open, Classified |
| Z-2619-2026 | Class I recall | LROGeneral Surgery Tray | Windstone Medical Packaging, Inc. | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Open, Classified |
| Z-2620-2026 | Class I recall | OGREar, Nose, And Throat Surgical Tray | Windstone Medical Packaging, Inc. | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Open, Classified |
| Z-2621-2026 | Class I recall | LROGeneral Surgery Tray | Windstone Medical Packaging, Inc. | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Open, Classified |
| Z-2622-2026 | Class I recall | LROGeneral Surgery Tray | Windstone Medical Packaging, Inc. | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Open, Classified |
| Z-2626-2026 | Class II recall | FGEStents, Drains And Dilators For The Biliary Ducts | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2627-2026 | Class II recall | FGEStents, Drains And Dilators For The Biliary Ducts | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2628-2026 | Class II recall | FGEStents, Drains And Dilators For The Biliary Ducts | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2629-2026 | Class II recall | FGEStents, Drains And Dilators For The Biliary Ducts | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2630-2026 | Class II recall | FGEStents, Drains And Dilators For The Biliary Ducts | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2631-2026 | Class II recall | FGEStents, Drains And Dilators For The Biliary Ducts | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2632-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2633-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2634-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2635-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2636-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2637-2026 | Class II recall | FDTDuodenoscope And Accessories, Flexible/Rigid | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. | Open, Classified |
| Z-2655-2026 | Class II recall | PXIThoracentesis Tray | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2656-2026 | Class II recall | PXIThoracentesis Tray | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2657-2026 | Class II recall | PXIThoracentesis Tray | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2658-2026 | Class II recall | LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2659-2026 | Class II recall | LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2660-2026 | Class II recall | NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2661-2026 | Class II recall | NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2662-2026 | Class II recall | PNDMidline Catheter | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2663-2026 | Class II recall | PNDMidline Catheter | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
| Z-2664-2026 | Class II recall | LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Open, Classified |
Data from FDA's public openFDA API, US public domain (CC0). Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are unrelated. DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration.