BEUDAMED
    FDA Enforcement Class II Ongoing

    CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

    Recall: Z-1824-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1824-2026
    Event ID
    98626
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 22, 2026
    Initiation Date
    March 16, 2026
    Classification Date
    April 16, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

    Reason

    On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.

    Code Info

    Medline Kit Number/SKU CIT7050F, UDI/DI each 10198459536656, UDI/DI case 40198459536657, Lot Number 25KLA002

    Distribution

    US Nationwide distribution in the state of South Carolina.

    Quantity

    640 kits