{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mentor",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91315",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "address_2": "N/A",
      "postal_code": "44060-1834",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA",
      "recall_number": "Z-0779-2023",
      "product_description": "VERIFY Dual Species Self-Contained Biological Indicators, 100 per box  Item Number: S3061    Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes",
      "product_quantity": "857 boxes",
      "reason_for_recall": "Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.",
      "recall_initiation_date": "20221212",
      "center_classification_date": "20230103",
      "report_date": "20230111",
      "code_info": "UDI: 10724995023833, 50724995023824 lot #230613"
    }
  ]
}