BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

    Recall: Z-1371-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1371-2026
    Event ID
    98188
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2026
    Initiation Date
    October 22, 2025
    Classification Date
    February 17, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

    Reason

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

    Code Info

    Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.

    Distribution

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

    Quantity

    9,542 units