BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

    Recall: Z-1403-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1403-2026
    Event ID
    98329
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2026
    Initiation Date
    January 7, 2026
    Classification Date
    February 17, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

    Reason

    Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

    Code Info

    1) DYNJ50806L, UDI-DI: 10195327344672(each), 40195327344673(case), Lot Number: 23FBK937

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    32 units