{
  "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": "Tiffin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97358",
      "recalling_firm": "American Contract Systems Inc",
      "address_1": "85 Shaffer Park Dr",
      "address_2": "",
      "postal_code": "44883-9290",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US distribution to states of:  IL and LA",
      "recall_number": "Z-2466-2025",
      "product_description": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) CYSTO, Model/Item Number ASCY24A;   2) CYSTO PACK, Model/Item Number BUCY78E;   3) CYSTO PACK, Model/Item Number LMCP22T;   4) TUR BASIN PACK, Model/Item Number LMTU31T;   5) CYSTO, Model/Item Number SACY80S;   6) UROLOGY PACK, Model/Item Number SPUR64F.",
      "product_quantity": "1127 units",
      "reason_for_recall": "During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.",
      "recall_initiation_date": "20250714",
      "center_classification_date": "20250828",
      "report_date": "20250903",
      "code_info": "1) Model/Item Number ASCY24A:  UDI/DI 00191072201621, Kit Lot Numbers:  12-7370111, 12-7388611, 12-7388611, 12-7139611, 12-7191911, 12-7231611, 12-7263911;  2) Model/Item Number BUCY78E:  UDI/DI 00191072235350, Kit Lot Numbers:  42-7962811;  3) Model/Item Number LMCP22T:  UDI/DI 00191072235510, Kit Lot Numbers:  42-8027411, 42-8106111, 42-7885511, 42-7823511;  4) Model/Item Number LMTU31T:  UDI/DI 00191072235527, Kit Lot Numbers:  42-7987311, 42-8059311, 42-8112211, 42-7832311, 42-7845011, 42-7914911;  5) Model/Item Number SACY80S:  UDI/DI 00191072233370, Kit Lot Numbers: 70-052954, 70-052248, 70-51139, 70-053309, 70-053805;   6) Model/Item Number SPUR64F:  UDI/DI 00191072238764, Kit Lot Numbers:  12-7394711, 12-7328411, 12-7096811, 12-7168211.",
      "more_code_info": ""
    }
  ]
}