BEUDAMED
    FDA Enforcement Class I Ongoing

    Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

    Recall: Z-1001-2026 · Reported January 14, 2026

    Enforcement

    Recall Number
    Z-1001-2026
    Event ID
    98060
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 14, 2026
    Initiation Date
    November 11, 2025
    Classification Date
    January 2, 2026
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351, United States

    Description

    Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

    Reason

    Devices are not suitable for organ transplant.

    Code Info

    Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709

    Distribution

    US Nationwide distribution in the states of FL, GA and Puerto Rico.

    Quantity

    52 units