{
  "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-2472-2025",
      "product_description": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N;   2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F;   3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N;   4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B;   5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B;   6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T;   7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.",
      "product_quantity": "588 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 AMAH40N:  UDI/DI 00191072235473, Kit Lot Numbers:  42-7886011, 42-7990911;  2)MODEL/ITEM NUMBER CCKM67F:  UDI/DI 00191072233578, Kit Lot Numbers:  70-053862, 70-053457, 70-053042, 70-052715, 70-052358, 70-051850, 70-051243;  3)MODEL/ITEM NUMBER HSTH03N:  UDI/DI 00191072189615, Kit Lot Numbers:  42-7115711;  4)MODEL/ITEM NUMBER MIAH65B:  UDI/DI 00191072235411, Kit Lot Numbers:  42-8134311;  5)MODEL/ITEM NUMBER MPWH01B:  UDI/DI 00191072233271, Kit Lot Numbers:  5436801;  6)MODEL/ITEM NUMBER SPKA57T:  UDI/DI 00191072235848, Kit Lot Numbers:  12-7400011, 12-7381311, 12-7358211, 12-7082111, 12-7157111, 12-7309911;  7)MODEL/ITEM NUMBER WVAH40H:  UDI/DI 00191072233004, Kit Lot Numbers:  42-7897411, 42-7966211.",
      "more_code_info": ""
    }
  ]
}