{ "companyId": "53355", "slug": "ethicon-endo-surgery-llc-53355", "name": "Ethicon Endo Surgery, LLC", "clearances": { "total": 184, "last12Months": 3, "first": "1992-09-09", "latest": "2026-05-11" }, "medianReviewDays": 85, "productCodeCount": 27, "recalls": { "total": 178, "openLast12Months": 1, "recent": [ { "resNumber": "Z-0147-2026", "productCode": "GDW", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-09-11", "reason": "The devices were shipped unsterilized." }, { "resNumber": "Z-1746-2025", "productCode": "GDW", "status": "Open, Classified", "recallClass": "Class I", "initiated": "2025-04-22", "reason": "Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death." }, { "resNumber": "Z-1513-2025", "productCode": "NEW", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-03-07", "reason": "Identified curing issues with the silicone during the needles manufacturing process." }, { "resNumber": "Z-1514-2025", "productCode": "NEW", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-03-07", "reason": "Identified curing issues with the silicone during the needles manufacturing process." }, { "resNumber": "Z-1515-2025", "productCode": "NEW", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-03-07", "reason": "Identified curing issues with the silicone during the needles manufacturing process." } ] }, "registration": { "sites": 2, "countries": [ "US" ] }, "productCodes": [ { "code": "GDW", "deviceName": "Staple, Implantable", "clearances": 44, "latest": "2026-05-11", "medianReviewDays": 57 }, { "code": "GCJ", "deviceName": "Laparoscope, General & Plastic Surgery", "clearances": 31, "latest": "2012-10-01", "medianReviewDays": 82 }, { "code": "LFL", "deviceName": "Instrument, Ultrasonic Surgical", "clearances": 29, "latest": "2023-02-28", "medianReviewDays": 73 }, { "code": "GEI", "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories", "clearances": 25, "latest": "2023-04-13", "medianReviewDays": 135 }, { "code": "OCW", "deviceName": "Endoscopic Tissue Approximation Device", "clearances": 11, "latest": "2007-08-15", "medianReviewDays": 88 }, { "code": "KNW", "deviceName": "Instrument, Biopsy", "clearances": 7, "latest": "2010-04-29", "medianReviewDays": 90 }, { "code": "GAG", "deviceName": "Stapler, Surgical", "clearances": 5, "latest": "2024-07-03", "medianReviewDays": 91 }, { "code": "FZP", "deviceName": "Clip, Implantable", "clearances": 4, "latest": "2023-08-29", "medianReviewDays": 31 }, { "code": "GEX", "deviceName": "Powered Laser Surgical Instrument", "clearances": 4, "latest": "2002-10-24", "medianReviewDays": 52 }, { "code": "OXC", "deviceName": "Mesh, Surgical, Absorbable, Staple Line Reinforcement", "clearances": 3, "latest": "2026-01-09", "medianReviewDays": 130 }, { "code": "FOZ", "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days", "clearances": 2, "latest": "2003-03-28", "medianReviewDays": 23 }, { "code": "HET", "deviceName": "Laparoscope, Gynecologic (And Accessories)", "clearances": 2, "latest": "2000-05-16", "medianReviewDays": 29 }, { "code": "KNQ", "deviceName": "Dilator, Esophageal", "clearances": 2, "latest": "2009-11-10", "medianReviewDays": 26 }, { "code": "NEU", "deviceName": "Marker, Radiographic, Implantable", "clearances": 2, "latest": "2002-04-12", "medianReviewDays": 49 }, { "code": "FDI", "deviceName": "Snare, Flexible", "clearances": 1, "latest": "2008-06-12", "medianReviewDays": 204 }, { "code": "FER", "deviceName": "Anoscope And Accessories", "clearances": 1, "latest": "2010-03-25", "medianReviewDays": 97 }, { "code": "FQH", "deviceName": "Lavage, Jet", "clearances": 1, "latest": "1997-12-16", "medianReviewDays": 71 }, { "code": "GAL", "deviceName": "Suture, Absorbable, Natural", "clearances": 1, "latest": "2004-11-19", "medianReviewDays": 30 }, { "code": "GBZ", "deviceName": "Catheter, Cholangiography", "clearances": 1, "latest": "1994-08-05", "medianReviewDays": 74 }, { "code": "GCM", "deviceName": "Endoscope, Rigid", "clearances": 1, "latest": "1996-01-26", "medianReviewDays": 78 }, { "code": "HIF", "deviceName": "Insufflator, Laparoscopic", "clearances": 1, "latest": "1999-02-03", "medianReviewDays": 90 }, { "code": "KCJ", "deviceName": "Applicator, Ent", "clearances": 1, "latest": "1992-09-09", "medianReviewDays": 49 }, { "code": "KNS", "deviceName": "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)", "clearances": 1, "latest": "2002-09-27", "medianReviewDays": 158 }, { "code": "LZA", "deviceName": "Polymer Patient Examination Glove", "clearances": 1, "latest": "2006-05-23", "medianReviewDays": 25 }, { "code": "MND", "deviceName": "Ligator, Esophageal", "clearances": 1, "latest": "2005-10-07", "medianReviewDays": 81 } ], "productCodesShown": 25, "productCodesTotal": "27", "recentClearances": [ { "kNumber": "K260196", "deviceName": "ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)", "productCode": "GDW", "decisionDate": "2026-05-11", "reviewDays": 109 }, { "kNumber": "K252906", "deviceName": "ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)", "productCode": "OXC", "decisionDate": "2026-01-09", "reviewDays": 119 }, { "kNumber": "K252739", "deviceName": "ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)", "productCode": "GDW", "decisionDate": "2025-12-17", "reviewDays": 111 }, { "kNumber": "K250835", "deviceName": "ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)", "productCode": "GDW", "decisionDate": "2025-05-14", "reviewDays": 55 }, { "kNumber": "K243276", "deviceName": "ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)", "productCode": "GDW", "decisionDate": "2025-02-25", "reviewDays": 132 }, { "kNumber": "K241630", "deviceName": "ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)", "productCode": "GDW", "decisionDate": "2024-10-28", "reviewDays": 144 }, { "kNumber": "K241629", "deviceName": "ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)", "productCode": "GAG", "decisionDate": "2024-07-03", "reviewDays": 27 }, { "kNumber": "K232313", "deviceName": "LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)", "productCode": "FZP", "decisionDate": "2023-08-29", "reviewDays": 27 }, { "kNumber": "K230387", "deviceName": "ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)", "productCode": "GEI", "decisionDate": "2023-04-13", "reviewDays": 58 }, { "kNumber": "K223760", "deviceName": "ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)", "productCode": "GDW", "decisionDate": "2023-03-15", "reviewDays": 90 } ], "nameVariants": { "total": "12", "shown": [ { "name": "ETHICON ENDO-SURGERY, INC.", "dataset": "device/registrationlisting", "method": "normalised" }, { "name": "ETHICON ENDO-SURGERY, LLC", "dataset": "device/registrationlisting", "method": "normalised" }, { "name": "Ethicon Endo Surgery, LLC", "dataset": "device/enforcement", "method": "normalised" }, { "name": "Ethicon Endo Surgery, LLC", "dataset": "device/recall", "method": "normalised" }, { "name": "Ethicon Endo Surgery, Inc.", "dataset": "device/510k", "method": "normalised" }, { "name": "Ethicon Endo Surgery, LLC", "dataset": "device/510k", "method": "normalised" }, { "name": "Ethicon Endo-Surgery", "dataset": "device/recall", "method": "normalised" }, { "name": "Ethicon Endo-Surgery", "dataset": "device/510k", "method": "normalised" } ] }, "sources": { "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Ethicon%20Endo%20Surgery%2C%20%20LLC%22", "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Ethicon%20Endo%20Surgery%2C%20%20LLC%22" }, "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51 }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2 }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53 }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:58:22Z", "ingestRun": 74 }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52 }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10 } ], "retrievedAt": "2026-08-11T14:48:53.030Z" }