{
  "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-1175-2023",
      "product_description": "Novafil Monofilament Polybutester Suture  Product Description:   8886 4002-41 NOVAFIL 3-0 BLU 90CM C14  8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2  8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2  8886 440123 NOVAFIL 5-0 BLU 45CM SBE3  8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4  8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6  8886 4410-13 NOVAFIL 6-0 BLU 45CM P10  8886 4410-03 NOVAFIL 7-0 BLU 45CM P10  8886 4422-43 NOVAFIL 3-0 BLU 45CM C14  8886 4424-51 NOVAFIL 2-0 BLU 75CM C16  8886 4450-41 NOVAFIL 3-0 BLU 75CM V26  8886 4452-51 NOVAFIL 2-0 BLU 75CM V20  8886 4459-61 NOVAFIL 0 BLU 75CM GS22  8886 4470-81 NOVAFIL* 2 BLU 150CM GS26  8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14  SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12  SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12  SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12  SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12  SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12  SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13  SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12  SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12",
      "product_quantity": "48492 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 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777.   Model #         Lot #:   8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY,  D1M2364FY 8886441013 D1M1007FY  D1M2364FY, 8886441003 D1M0369FY  D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y,  D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY,  D2B0773FY  D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY",
      "more_code_info": ""
    }
  ]
}