{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Mentor",
      "address_1": "5960 Heisley Rd",
      "reason_for_recall": "Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.",
      "address_2": "",
      "product_quantity": "6,028 units",
      "code_info": "Model #6500 & 7500",
      "center_classification_date": "20131231",
      "distribution_pattern": "Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico.    Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.",
      "state": "OH",
      "product_description": "SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH    The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.",
      "report_date": "20140108",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Steris Corporation",
      "recall_number": "Z-0616-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67002",
      "termination_date": "20140616",
      "more_code_info": "",
      "recall_initiation_date": "20131121",
      "postal_code": "44060-1834",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}