BEUDAMED
    FDA Enforcement Class II Ongoing

    AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP 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.

    Recall: Z-0910-2026 · Reported December 17, 2025

    Enforcement

    Recall Number
    Z-0910-2026
    Event ID
    97986
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2025
    Initiation Date
    November 19, 2025
    Classification Date
    December 11, 2025
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP 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.

    Reason

    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).

    Code Info

    Lot Code: UDI: 00724995176662, 00724995176679, 00724995176655 Serial numbers of distributed units: 3619725008, 3619725011, 3619725013, 3621625010, 3621625011, 3621625013, 3621625014, 3621625015, 3621925001, 3621925002, 3621925005, 3621925010, 3622425005, 3622725005, 3622725011, 3622725012, 3623125006, 3623425016, 3623825008, 3624025002, 3624025008, 3624525007

    Distribution

    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.

    Quantity

    22