BEUDAMED
    FDA Enforcement Class II Ongoing

    Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

    Recall: Z-0929-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0929-2026
    Event ID
    98045
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 24, 2025
    Initiation Date
    November 14, 2025
    Classification Date
    December 15, 2025
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351, United States

    Description

    Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

    Reason

    Potential for incomplete seal on header bag.

    Code Info

    Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.

    Distribution

    US distribution to GA, IL, NE, MD.

    Quantity

    90 units