{
  "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-0176-2026",
      "product_description": "Medical convenience kits     Item Number/Description  ANCV78BC\tHEART PACK - 205947  HGCV05K\tCV SET UP PACK  MHPP97AR\tPACEMAKER PACK- 206010  UDBH37AW\tBASIC HEART PACK - 206044  UHPP82AH\tPERIPHERAL PACK - 209533  UICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)  UICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I\tVASCULAR PACK",
      "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": "ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380;  ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A;  HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464;  MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A;  UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335;  UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A;  UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A;  UICT16F UDI-DI 191072150431 Lot 8000411 Bag serial number N/A Lot 8331311 Bag serial number  17627819 Lot 8429011 Bag serial number 17749736;  UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A;  UIVA75J UDI-DI 191072235602 Lot 8422011 Bag serial number 68667536  * If Bag serial number is \"n/a\", then all of that lot is affected",
      "more_code_info": ""
    }
  ]
}