{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94196",
      "recalling_firm": "Cook Incorporated",
      "address_1": "750 N Daniels Way",
      "address_2": "",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES,  GB, HK, IE, IL, IN, IT, NZ, SG.",
      "recall_number": "Z-1532-2024",
      "product_description": "Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.    REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN):    1) JCD10.0-38-20- COONS\tG03928  2) JCD12.0-38-20- COONS\tG03929  3) JCD14.0-38-20- COONS\tG03932  4) JCD16.0-38-20- COONS\tG03947  5) JCD18.0-38-20- COONS\tG04051  6) JCD20.0-38-20- COONS\tG04264  7) JCD22.0-38-20- COONS\tG04443  8) JCD6.0-38-20- COONS\tG04221  9) JCD8.0-38-20- COONS\tG03927",
      "product_quantity": "4,856 units",
      "reason_for_recall": "Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility",
      "recall_initiation_date": "20240301",
      "center_classification_date": "20240412",
      "report_date": "20240424",
      "code_info": "Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20- COONS (01)00827002039285(17) 15787236; 2) JCD12.0-38-20- COONS (01)00827002039292(17) 15774752, 15774753; 3) JCD14.0-38-20- COONS (01)00827002039322(17) 15797981, 15784149, 15797975 15797976, 15797982; 4) JCD16.0-38-20- COONS (01)00827002039476(17) 15794190, 15794191, 15808405; 5) JCD18.0-38-20- COONS (01)00827002040519(17) 15794189, 15797973; 6) JCD20.0-38-20- COONS (01)00827002042643(17) 15784152, 15784156, 15784158 15784164, 15794195, 15804033; 7) JCD 38-20- COONS (01)00827002044432(17) 15767086, 15784163, 15794203,  15806060; 8) JCD6.0-38-20- COONS (01)00827002042216(17)    15787237, 15787244 9) JCD8.0-38-20- COONS (01)00827002039278(17)    15797985, 15797999, 15798003",
      "more_code_info": ""
    }
  ]
}