BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.

    Recall: Z-1331-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1331-2026
    Event ID
    98284
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 18, 2026
    Initiation Date
    December 24, 2025
    Classification Date
    February 9, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.

    Reason

    Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

    Code Info

    1) Kit SKU DYNDH1576, UDI/DI 10193489437041, Lot Number 25EBP737; 2) Kit SKU RWM-DC57KC, UDI/DI 10889942582013, Lot Number 25EBE082.

    Distribution

    US Nationwide distribution.

    Quantity

    7380 kits