{
  "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": "Grimes",
      "state": "IA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97659",
      "recalling_firm": "American Contract Systems Inc.",
      "address_1": "1601 Se Gateway Dr Ste 120",
      "address_2": "",
      "postal_code": "50111-5223",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
      "recall_number": "Z-0180-2026",
      "product_description": "Medical convenience kits     Item Number/Description  HSAN63N\tANGIO PACK  IHAN02W\tANGIOGRAPHY PACK  MHCA98AK\tCORONARY ANGIO PACK- 205991  RCAN45C\tANGIO CUSTOM RCH  UDCO10F\tCVL CORONARY PACK   219224",
      "product_quantity": "32,433 total",
      "reason_for_recall": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
      "recall_initiation_date": "20250904",
      "center_classification_date": "20251016",
      "report_date": "20251022",
      "code_info": "ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number  68119740;  HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number  N/A;  IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number  N/A;  MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A;  RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542;  UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A  * If bag serial number is listed as \"N/A\", then whole lot is affected",
      "more_code_info": ""
    }
  ]
}