BEUDAMED
    FDA Enforcement Class II Ongoing

    Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

    Recall: Z-2230-2026 · Reported June 3, 2026

    Enforcement

    Recall Number
    Z-2230-2026
    Event ID
    98805
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2026
    Initiation Date
    April 13, 2026
    Classification Date
    May 22, 2026
    Address
    1220 Old Alpharetta Rd Ste 320, Alpharetta, GA, 30005-3946, United States

    Description

    Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

    Reason

    Nitrile Exam Glove failed to meet specifications chemical permeation performance.

    Code Info

    REF: 48771/UDI: 30680651487712 (Package)20680651487715 (Primary)90680651487714 (Unit of Use) ; 48772/30680651487729 (Package)20680651487722 (Primary)90680651487721 (Unit of Use);48773/30680651487736 (Package)20680651487739 (Primary)90680651487738 (Unit of Use);48774/UDI: 30680651487743 (Package)20680651487746 (Primary) 90680651487745 (Unit of Use);48775/UDI:30680651487750 (Package)20680651487753 (Primary)90680651487752 (Unit of Use)

    Distribution

    US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.

    Quantity

    452,500 units