BEUDAMED
    FDA Recall Open, Classified

    Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

    Recall: Z-2142-2025 · Initiated June 18, 2025

    Recall

    Recall Number
    Z-2142-2025
    Event Number
    96982
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    KQT
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    June 18, 2025
    Posted
    July 21, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. 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).

    Action

    Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.

    Distribution

    International distribution to the country of Japan.

    Quantity

    1 unit