{
  "code": "EFQ",
  "deviceName": "Gauze/Sponge, Internal",
  "deviceClass": "U",
  "regulationNumber": null,
  "panel": "Unknown",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 271,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 66,
    "last12Months": 18
  },
  "reviewDays": {
    "median": 39,
    "sampleSize": 271
  },
  "recalls": {
    "total": 13,
    "recent": [
      {
        "resNumber": "Z-2458-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "AMD Medicom Inc.",
        "firmAsPublished": "AMD Medicom Inc.",
        "reason": "Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2459-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "AMD Medicom Inc.",
        "firmAsPublished": "AMD Medicom Inc.",
        "reason": "Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2639-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Teleflex, Inc.",
        "firmAsPublished": "TELEFLEX LLC",
        "reason": "Due to out-of-specification, or potential out-of-specification, levels of endotoxins",
        "initiated": "2026-05-07"
      },
      {
        "resNumber": "Z-0772-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Teleflex, Inc.",
        "firmAsPublished": "TELEFLEX LLC",
        "reason": "Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.",
        "initiated": "2022-09-28"
      },
      {
        "resNumber": "Z-1118-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Steris Corporation",
        "firmAsPublished": "Steris Corporation",
        "reason": "Product not approved for release for US distribution",
        "initiated": "2022-03-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K991757",
      "deviceName": "NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE",
      "applicant": "Furlong Industries",
      "company": "Furlong Industries",
      "decisionDate": "1999-08-12",
      "dateReceived": "1999-05-24"
    },
    {
      "kNumber": "K991215",
      "deviceName": "SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S",
      "applicant": "Symtex Healthcare Corp.",
      "company": "Symtex Healthcare Corp.",
      "decisionDate": "1999-06-11",
      "dateReceived": "1999-04-09"
    },
    {
      "kNumber": "K990974",
      "deviceName": "VITOP DRESSING",
      "applicant": "Wonder & Bioenergy Hi-Tech America, Inc.",
      "company": "Wonder & Bioenergy Hi-Tech America, Inc.",
      "decisionDate": "1999-06-09",
      "dateReceived": "1999-03-23"
    },
    {
      "kNumber": "K990584",
      "deviceName": "GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE",
      "applicant": "Broadline Medical Industries",
      "company": "Broadline Medical Industries",
      "decisionDate": "1999-04-23",
      "dateReceived": "1999-02-23"
    },
    {
      "kNumber": "K984187",
      "deviceName": "CROSSTEX NON-WOVEN SPONGES",
      "applicant": "Crosstex Intl.",
      "company": "Crosstex Intl.",
      "decisionDate": "1999-02-18",
      "dateReceived": "1998-11-23"
    },
    {
      "kNumber": "K983016",
      "deviceName": "GAUZE, SPONGES, CAT # 11-003",
      "applicant": "Vitalcare Group, Inc.",
      "company": "Vitalcare Group, Inc.",
      "decisionDate": "1999-02-12",
      "dateReceived": "1998-08-28"
    },
    {
      "kNumber": "K983348",
      "deviceName": "DYNAREX TRACHEOSTOMY SPONGE",
      "applicant": "Dynarex Corp.",
      "company": "Dynarex Corporation",
      "decisionDate": "1998-12-11",
      "dateReceived": "1998-09-23"
    },
    {
      "kNumber": "K983450",
      "deviceName": "STARRYSHINE GAUZE SPONGE",
      "applicant": "T.C. Dental Products, Inc.",
      "company": "T.C. Dental Products, Inc.",
      "decisionDate": "1998-11-12",
      "dateReceived": "1998-09-30"
    },
    {
      "kNumber": "K982648",
      "deviceName": "JOAN II",
      "applicant": "Celanese Acetate Co.",
      "company": "Celanese Acetate Co.",
      "decisionDate": "1998-09-30",
      "dateReceived": "1998-07-29"
    },
    {
      "kNumber": "K980791",
      "deviceName": "DUMEX PAK-ITS WOVEN RIBBON PACKING",
      "applicant": "Dumex Medical Surgical Products, Ltd.",
      "company": "Dumex Medical Surgical Products, Ltd.",
      "decisionDate": "1998-04-29",
      "dateReceived": "1998-03-02"
    }
  ],
  "topApplicants": [
    {
      "name": "Mcneil Healthcare, Inc.",
      "count": 14
    },
    {
      "name": "Ormed Mfg., Inc.",
      "count": 14
    },
    {
      "name": "American Medical Disposable, Inc.",
      "count": 13
    },
    {
      "name": "Ritmed, Inc.",
      "count": 10
    },
    {
      "name": "Certified Safety Mfg., Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Mcneil Healthcare, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Ormed Mfg., Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "American Medical Disposable, Inc.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Ritmed, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Certified Safety Mfg Inc",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 17.84989661592794,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 16.00049912903832,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 17.109566611139567,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 18.92068997498481,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 15.800194250917544,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 17.537985518580143,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 6,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "EFQ (Gauze/Sponge, Internal) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2458-2026, Z-2459-2026, Z-2639-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2458-2026",
          "Z-2459-2026",
          "Z-2639-2026"
        ],
        "severity": 75
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AEFQ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEFQ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEFQ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEFQ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEFQ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEFQ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEFQ"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.691Z"
}