BEUDAMED
    FDA Enforcement Class II Ongoing

    Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

    Recall: Z-2143-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2143-2025
    Event ID
    96982
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2025
    Initiation Date
    June 18, 2025
    Classification Date
    July 21, 2025
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

    Reason

    Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

    Code Info

    Model Number: 194. UDI-DI: 00821925002586. All lot numbers

    Distribution

    International distribution to the country of Japan.

    Quantity

    11 units