BEUDAMED
    FDA Recall Open, Classified

    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

    Recall: Z-1851-2026 · Initiated March 23, 2026

    Recall

    Recall Number
    Z-1851-2026
    Event Number
    98550
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 23, 2026
    Posted
    April 17, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

    Reason

    Potential for detachment of a distal tip component of the device during use.

    Action

    Olympus notified consignees on about 03/23/2026 via emailed letter. Consignees were instructed to immediately cease use of all THUNDERBEAT II devices, examine inventory for affected product and quarantine any on hand, and complete, return the Reply Form provided and arrange for the return of all affected units in inventory. Consignees were also instructed to notify other users if the affected products were transferred or further distributed.

    Distribution

    International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

    Quantity

    830 units