{
  "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-2471-2025",
      "product_description": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E;   2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.",
      "product_quantity": "50 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 GRRB10E:  UDI/DI 00191072236371, Kit Lot Numbers:  42-8157011, 42-8126811;  2) MODEL/ITEM NUMBER SPVH62P:  UDI/DI 00191072238771, Kit Lot Numbers:  12-7322911, 12-7384911.",
      "more_code_info": ""
    }
  ]
}