BEUDAMED
    FDA Recall Open, Classified

    Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

    Recall: Z-1004-2026 · Initiated November 19, 2025

    Recall

    Recall Number
    Z-1004-2026
    Event Number
    98032
    Firm
    Vortex Surgical Inc.
    FEI Number
    3013002167
    Product Code
    HQB
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    November 19, 2025
    Posted
    December 30, 2025
    Address
    4 Research Park Dr, Ste 124, Saint Charles, MO, 63304-5639

    Description

    Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

    Reason

    Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

    Action

    Vortex Surgical Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/19/2025 via email. The notice explained the issue, risk to health, and requested the use of the product be discontinued. The firm requested the response to be emailed to: [email protected] for replacement or refund. Customer Service will provide a return label for any unused products.

    Distribution

    US and Japan

    Quantity

    221 units