BEUDAMED
    FDA Recall Open, Classified

    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

    Recall: Z-0061-2026 · Initiated September 11, 2025

    Recall

    Recall Number
    Z-0061-2026
    Event Number
    97441
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    EOQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 11, 2025
    Posted
    October 16, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

    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.

    Action

    An URGENT Medical Device Correction notification dated 9/11/25 was mailed to consignees to notify them of this recall action. Consignees are asked to carefully read the recall notification and identify any affected devices in their inventory. Consignees are to ensure all personnel are knowledgeable and aware of the updated IFU. Consignees are to acknowledge receipt of the recall notification through Olympus' web portal at https://olympusamerica.com/recall. Forward the provided recall notification if product was further distributed. Consignees with any questions can contact Cynthia Ow by phone at 647-999-3203 or by email at [email protected].

    Distribution

    US Nationwide Distribution.

    Quantity

    665 units US; 2,250 units OUS