{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "North Haven",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91324",
      "recalling_firm": "Covidien, LP",
      "address_1": "60 Middletown Ave",
      "address_2": "N/A",
      "postal_code": "06473-3908",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe",
      "recall_number": "Z-1174-2023",
      "product_description": "Monosof Monofilament Nylon sutures:  Product Description    CN-724 MONOSOF* 1 BLK 100CM GS25 X36\t\t\t\t\t\t\t\t\t  CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36\t\t\t\t\t\t\t\t\t  CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90\t\t\t\t\t\t\t\t\t  CN-793 MONOSOF* 1 BLK 100CM GCC90 X36\t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12\t\t\t\t\t\t\t\t\t  CN-830-L MONOSOF* 1 BLK 150CM LP GS25\t\t\t\t\t\t\t\t\t  N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12\t\t\t\t\t\t\t\t\t  SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36\t\t\t\t\t\t\t\t\t  SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12\t\t\t\t\t\t\t\t\t  SN-247 MONOSOF* 3-0 BLK 90CM C23 X36\t\t\t\t  \t\t\t\t  SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12\t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12\t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12\t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12\t\t\t\t\t\t\t\t\t  SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12\t\t\t\t\t\t\t\t\t  SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12\t\t\t\t\t\t\t\t\t  SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12\t\t\t\t\t\t\t\t\t  SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36\t\t\t\t\t\t\t\t\t  SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36\t\t\t\t\t\t\t\t\t  SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36\t\t\t\t\t\t\t\t\t  SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36\t\t\t\t\t\t\t\t\t  SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12\t\t\t\t\t\t\t\t\t  SN-630 MONOSOF* 4-0 BLK 75CM C22 X36\t\t\t\t\t\t\t\t\t  SN-643 MONOSOF* 5-0 BLK 75CM C13 X36\t\t\t\t\t\t\t\t\t  SN-667G MONOSOF* 6-0 BLK 45CM C1 X12\t\t\t\t\t\t\t\t\t  SN-694 MONOSOF* 2-0 BLK 90CM C18 X36\t\t\t\t\t\t\t\t\t  SN-871 MONOSOF* 5-0 BLK 45CM C1 X36\t\t\t\t\t\t\t\t\t  SN-872 MONOSOF* 4-0 BLK 45CM C1 X36\t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM\t\t\t\t\t\t\t\t\t  \t\t\t\t\t\t\t\t\t  SUT N-59 MONOSOF 2-0 BLK 6X45CM PCT",
      "product_quantity": "54288 units",
      "reason_for_recall": "Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact",
      "recall_initiation_date": "20221202",
      "center_classification_date": "20230225",
      "report_date": "20230308",
      "code_info": "GTIN: 20884521075105, 20884521075235, 10884521075238, 20884521075143, 10884521635395, 20884521077857, 20884521075372, 20884521078090, 20884521077994, 20884521079073, 10884521080348, 20884521080345, 20884521080321, 10884521080324, 10884521078758, 20884521078755, 20884521078182, 20884521078045, 20884521075129, 10884521635371, 20884521127675, 20884521079844, 20884521079028, 20884521079325, 10884521079328, 20884521079097, 10884521079090, 20884521079202, 20884521079448, 20884521076829, 10884521075146, 20884521080093, 20884521079042, A8845210765103, 20884521076812, 20884521077987, 20884521079134, 10884521079137,  Model #    Lot #   CN-724    D1B2528Y   CN-791    D1L1776Y   CN-79112    D1L1776Y   CN-793    D1D2772Y       D2B2754Y   CN-79312    D1D2772Y   CN-830-L    D1D2705Y   N-2781K    D1L2330Y   SN-1647    D2E2028FY   SN-1647G    D2B2227FY   SN-247    D1D3222FY       D2B0043FY   SN-3686    D2E2761FY       D2F0402FY   SN-3695    D1G0954FY       D1L0957FY       D2C1333FY       D2E2762FY   SN-3697    D1L1710FY       D2C1211FY   SN-3965    D1E1222Y   SN-5660G    D1L0922FY   SN-5665G    D1L0774FY   SN-5690G    D1M1283FY   SN-5691    D2D0703FY   SN-5694    D1J1230FY   SN-5696    D1M2419FY   SN-5697    D2F0399FY   SN-5767G    D2A0554FY   SN-630    D1M1286FY   SN-643    D2B0369FY   SN-667G    D1L2502FY   SN-694    D2C0324FY   SN-871    D1K3362FY   SN-872    D1K2654FY       D1M2450FY   GNJ-283    D1E0555Y       D1E0750Y   N-59    D2D2350Y",
      "more_code_info": ""
    }
  ]
}