BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1004-2026 · Reported January 7, 2026

    Enforcement

    Recall Number
    Z-1004-2026
    Event ID
    98032
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vortex Surgical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 7, 2026
    Initiation Date
    November 19, 2025
    Classification Date
    December 30, 2025
    Address
    4 Research Park Dr Ste 124, N/A, Saint Charles, MO, 63304-5639, United States

    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.

    Code Info

    UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040

    Distribution

    US and Japan

    Quantity

    221 units