BEUDAMED
    FDA Enforcement Class I Ongoing

    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

    Recall: Z-2102-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2102-2025
    Event ID
    97121
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intersurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 23, 2025
    Initiation Date
    June 17, 2025
    Classification Date
    July 11, 2025
    Address
    5010 Campuswood Dr Ste 102, N/A, East Syracuse, NY, 13057-1561, United States

    Description

    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

    Reason

    Potential for faulty devices as a result of depleted batteries.

    Code Info

    Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.

    Distribution

    US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.

    Quantity

    2,152 pieces