BEUDAMED
    FDA Enforcement Class II Ongoing

    GS ENDOSCOPY PACK. Medical convenience kit.

    Recall: Z-2249-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2249-2025
    Event ID
    97149
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 13, 2025
    Initiation Date
    June 11, 2025
    Classification Date
    August 4, 2025
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    GS ENDOSCOPY PACK. Medical convenience kit.

    Reason

    CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

    Code Info

    Model No. NAMC421-10, NAMC421-11, NAMC421-12; UDI: 10809160374597, 10809160417539, 10809160435779; Kit Lot No. 1584375, 1588403, 1605341, 1615427, 1615428, 1627706, 1628153, 1628008, 1628009, 1628647, 1632992.

    Distribution

    Domestic: CA, IL, MD, OH, PA, TX, WA.

    Quantity

    816 units