BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

    Recall: Z-1853-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1853-2026
    Event ID
    98550
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2026
    Initiation Date
    March 23, 2026
    Classification Date
    April 17, 2026
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

    Reason

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

    Code Info

    Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.

    Distribution

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

    Quantity

    3,360 units