BEUDAMED
    FDA Recall Open, Classified

    Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

    Recall: Z-1381-2026 · Initiated October 22, 2025

    Recall

    Recall Number
    Z-1381-2026
    Event Number
    98188
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    LFL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 22, 2025
    Posted
    February 17, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

    Reason

    Firm is initiating a removal due to continued reports of adverse events.

    Action

    An URGENT MEDICAL DEVICE PRODUCT REMOVAL notification was mailed to consignees on 12/22/25. The notification instructs consignees to examine inventory for affected devices, immediately cease use and quarantine devices, and contact Customer Service at 1-800-848-9024 (option 2) to obtain a Return Materials Authorization. Credit will be issued to consignees upon return of devices. If product has been further distributed, consignees are to forward the provided notification. Consginees with any questions can contact Cynthia Ow at [email protected] or by phone at 674-999-3203.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

    Quantity

    140 units