{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "217380",
      "product_res_number": "Z-0909-2026",
      "event_date_initiated": "2025-11-19",
      "event_date_posted": "2025-12-11",
      "recall_status": "Open, Classified",
      "res_event_number": "97986",
      "product_code": "MEC",
      "product_description": "AMSCO 7052HP Washer/Disinfector\nModel/Catalog Number: 7052HP\n \nProduct Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.",
      "code_info": "Lot Code: UDI:00724995176587, 00724995176594, 00724995176570\nSerial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002",
      "firm_fei_number": "1527821",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "city": "Mentor",
      "state": "OH",
      "postal_code": "44060-1834",
      "additional_info_contact": "Michelle LaVan\n440-2597417",
      "reason_for_recall": "Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).",
      "root_cause_description": "Process control",
      "action": "On November 19, 2025, firm began notifying customers via Urgent Medical Device Field Correction letters. All affected customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their units to perform the correction. If the affected unit has not been installed yet, the correction will be performed as part of the installation process.\n\nUsers can continue to use their units prior to completion of the correction. Under normal operation, the system is designed to detect such electrical arcing specifically, indicating a  Drying Over Temperature Switch Tripped  alarm. Should your unit alarm, abort the cycle, turn off power to the unit, and contact STERIS.",
      "product_quantity": "10",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.",
      "openfda": {
        "registration_number": [
          "8043629",
          "9616031",
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        ],
        "fei_number": [
          "3021244152",
          "3015136927",
          "3027509245",
          "3012006473",
          "1825014",
          "3004097451",
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          "3021233712",
          "3030516433",
          "3010653034",
          "1000273801",
          "3010208143",
          "3015977541"
        ],
        "device_name": "Disinfector, Medical Devices",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6992",
        "device_class": "2",
        "k_number": [
          "K911120",
          "K081094"
        ]
      }
    }
  ]
}