BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

    Recall: Z-2104-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2104-2026
    Event ID
    98642
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    January 7, 2026
    Classification Date
    May 7, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

    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) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21BFA109; 2) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21EFA047; 3) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21FFA074; 4) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21GFA025; 5) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21HFA112; 6) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21IFA100; 7) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA039; 8) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA139; 9) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21KFA114; 10) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22BFA066; 11) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22CFA086; 12) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22DFA081; 13) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22IFA036; 14) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22JFA111; 15) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22LFA068; 16) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA049; 17) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA090; 18) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA006; 19) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA124; 20) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23CFA070; 21) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23DFA024; 22) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA007; 23) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA070; 24) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23GFA079; 25) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA039; 26) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA117; 27) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA178; 28) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23IFA139; 29) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23JFA065; 30) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA006; 31) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA054; 32) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23LFA050; 33) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24BFA115; 34) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24FFA115; 35) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24GFA027; 36) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24IFA085; 37) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA035; 38) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA136; 39) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24KFA099; 40) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25CFA033; 41) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25DFA033; 42) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25FFA025; 43) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25GFA099; 44) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25IFA006

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    13025 units