{
  "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": "Waukegan",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91350",
      "recalling_firm": "Stradis Healthcare",
      "address_1": "3600 Burwood Dr",
      "address_2": "",
      "postal_code": "60085-8399",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.",
      "recall_number": "Z-0931-2023",
      "product_description": "Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile",
      "product_quantity": "920 units",
      "reason_for_recall": "Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.",
      "recall_initiation_date": "20221215",
      "center_classification_date": "20230111",
      "report_date": "20230118",
      "code_info": "a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660;    b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466",
      "more_code_info": ""
    }
  ]
}