BEUDAMED
    FDA Recall Open, Classified

    Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

    Recall: Z-1338-2026 · Initiated January 2, 2026

    Recall

    Recall Number
    Z-1338-2026
    Event Number
    98298
    Firm
    AVID Medical, Inc.
    FEI Number
    1047429
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    January 2, 2026
    Posted
    February 9, 2026
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

    Reason

    Tyvek bag seal issue which may compromise sterility of the kit.

    Action

    AVID Medical notified consignees on about 01/02/2026 via emailed URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter. Consignees were instructed to segregate and quarantine all affected lots, discard all affected lots on hand, and complete and return the provided Recall Response form. Distributors were instructed to notify all customers if further distributed.

    Distribution

    US Nationwide distribution in the states of New Jersey.

    Quantity

    1,500 units