BEUDAMED
    FDA Enforcement Class II Ongoing

    Halyard, EP LAB PK. Catalog Number: ESJH009-03.

    Recall: Z-0927-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0927-2026
    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, EP LAB PK. Catalog Number: ESJH009-03.

    Reason

    Potential for incomplete seal on header bag.

    Code Info

    Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.

    Distribution

    US distribution to GA, IL, NE, MD.

    Quantity

    240 units