BEUDAMED
    FDA Enforcement Class I Ongoing

    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

    Recall: Z-0058-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0058-2026
    Event ID
    97441
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 22, 2025
    Initiation Date
    September 11, 2025
    Classification Date
    October 16, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

    Reason

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Code Info

    Model No. BF-P60; UDI: 4953170339196; All Serial No.

    Distribution

    US Nationwide Distribution.

    Quantity

    1,007 units US; 5,443 units OUS