BEUDAMED
    FDA Enforcement Class II Ongoing

    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

    Recall: Z-2344-2025 · Reported August 27, 2025

    Enforcement

    Recall Number
    Z-2344-2025
    Event ID
    97279
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LUMENIS, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2025
    Initiation Date
    July 22, 2025
    Classification Date
    August 21, 2025
    Address
    Yokneam Ind. Park, 6, Ha-Kidma, Yokne'Am Ilit, N/A, N/A, Israel

    Description

    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

    Reason

    The potential for unsterilized product within finished product labeled as sterile.

    Code Info

    UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;

    Distribution

    Domestic: PA, WI; International: Germany, India;

    Quantity

    13 units