{
  "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-1181-2023",
      "product_description": "Ti-Cron Coated Braided Polyester Suture  Product Description  88862775-31 TICRON* 4-0 BLU 75CM CV327DA  88862880-41 TICRON* 3-0 WHI 75CM Y31DA  88863012-61 TICRON* 0 BLU 90CM C16 X36  88863015-61 TICRON* 0 BLU 120CM V20X36  88863017-51 TICRON* 2-0 BLU 120CM SKX36  88863026-71 TICRON* 1 BLU 75CM HOS12X36  88863035-51 TICRON 2-0 BLU 105CM CV305DA  88863047-41 TICRON* 3-0 BLU 45CM C13X36  88863048-51 TICRON* 2-0 BLU 75CM C13X36  88863050-61 TICRON* 0 BLU 75CM C14 X36  88863054-51 TICRON* 2-0 BLU 75CM C17X36  88863056-89 TICRON* 5 BLU 45CM GS18X12  88863059-53 TICRON* 2-0 BLU 45CM P24X12  88863070-51 TICRON* 2-0 BLU 75CM C15X36  88863088-51 TICRON* 2-0 BLU 75CM Y5X36  88863090-51 TICRON 2-0 BLU 75CM GS21X36  88863092-71 TICRON* 1 BLU 75CM KV37X36  88863109-43 TICRON* 3-0 BLU 45CM P22X12  88863111-79 TICRON* 5 BLU 75CM HGS21X36  88863119-61 TICRON* 0 BLU 75CM KV34X36  88863154-09 TICRON* 4 BLU 75CM GS11X36  88863159-31 TICRON* 4-0 BLU 90CM KV5DA  88863160-41 TICRON* 3-0 BLU 90CM Y31DA  88863163-61 TICRON* 0 BLU 75CM SC1 X36  88863185-41 TICRON* 3-0 BLU 75CM CV305  88863186-41 TICRON* 3-0 BLU 75CM CV331  88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P  88863226-41 TICRON* 3-0 BLU 60CM CV330DA  88863280-21 TICRON* 5-0 BLU 75CM CV301DA  88863280-31 TICRON* 4-0 BLU 75CM CV301DA  88863309-71 TICRON* 1 BLU 75CM GS11X36  88863369-31 TICRON* 4-0 BLU 90CM CV316DA  88863393-51 TICRON* 2-0 BLU 90CM CV300DA  CD-3123K TICRON* 5-0 WHI 45CM SS24 DA",
      "product_quantity": "40152 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: 20884521062303, 20884521059570, 20884521060101, 20884521059006, 20884521059396, 20884521060682, 20884521059013, 10884521059290, 20884521059297, 20884521059280, 10884521061194, 20884521061191, 20884521062327, 20884521059204, 20884521060637, 20884521105192, 20884521062921, 10884521058620, 20884521058627, 20884521060170, 20884521059471, 10884521061293, 20884521061290, 20884521061641, 20884521059020, 10884521060432, 20884521060439, 20884521104300, 20884521063034, 20884521062655, 10884521062320, 10884521059900, 20884521059907, 20884521060361, 20884521059372, 20884521059990, 20884521060095, 20884521059464, 20884521062488, 10884521061507, 20884521061504.  Model Number Lot # 8886277531 D1M0276Y 8886288041 D1L1698Y 8886301261 D1D3149FY 8886301561 D1E1922Y 8886301751 D2A0889Y 8886302671 D2C1802Y 8886303551 D1L0984Y 8886304741 D1G1844FY 8886304851 D1G0895FY 8886305061 D2C1969FY 8886305451 D1D3218FY 8886305689 D2D0199Y 8886305953 D1M1287FY 8886307051 D1D2540FY 8886308851 D2B2868Y 8886309051 D2B1332Y 8886309271 D2C2450Y 8886310943 D2C2451FY 8886311179 D1D2597Y 8886311961 D1M1166Y 8886315409 D2B2884Y 8886315931 D2B0542Y 8886316041 D1L1697Y  D2B0543Y 8886316361 D1E0506Y 8886318541 D1J1639Y  D1M2717Y  D1M2851Y 8886318641 D1M2844Y  D2A0933Y  D2E0947Y  D2E1925Y 8886321251 D2E3008Y 8886322641 D2A0451Y 8886328021 D1D0290Y 8886328031 D1L0721Y  D1L2169Y  D2B2861Y 8886330971 D2D2188Y 8886336931 D2B2738Y  D2E0660Y  D2F0767Y 8886339351 D1M0107Y  D1M1299Y CD3123K D2B2213Y",
      "more_code_info": ""
    }
  ]
}