BEUDAMED
    FDA Enforcement Class II Ongoing

    Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

    Recall: Z-0016-2026 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-0016-2026
    Event ID
    97535
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Getinge Disinfection Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2025
    Initiation Date
    August 29, 2025
    Classification Date
    October 1, 2025
    Address
    Ljungadalsgatan 11, N/A, Vaxjo, N/A, N/A, Sweden

    Description

    Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

    Reason

    Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

    Code Info

    Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.

    Distribution

    Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    902 units