{
  "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-0174-2026",
      "product_description": "Medical convenience kits     Item Number/Description  BUCY78E\tCYSTO PACK  CMCP10X\tCYSTO PACK - 205972  IHCY10Y\tCYSTO PACK  MHCY35AE\tCYSTO PACK- 212487  PLBY52E\tCYSTO PACK  UDCY31Z\tCYSTO PACK - 206047  UICY28L\tMOR CYSTO 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": "BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421;  CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number  17622370;  IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124;  MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A;  PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184;  UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283;  UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number  17598793  * If Bag serial number is listed as \"N/A\", then whole lot is affected",
      "more_code_info": ""
    }
  ]
}