BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2230-2026 · Initiated April 13, 2026

    Recall

    Recall Number
    Z-2230-2026
    Event Number
    98805
    Firm
    O & M HALYARD INC
    FEI Number
    3014421917
    Product Code
    LZC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 13, 2026
    Posted
    May 22, 2026
    Address
    1220 Old Alpharetta Rd, Ste 320, Alpharetta, GA, 30005-3946

    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.

    Action

    On August 13, 2026, O&M Halyard, Inc. issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. O&M Halyard ask consignees to take the following actions: 1. REVIEW your inventory for the affected product code(s) and specific lot number(s). 2. DESTROY or DISCARD the product in accordance with the facility s standard disposal procedure. 3. COMMUNICATE the recall notification to your staff to ensure awareness of it. 4. If any of the affected lot(s) identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Any adverse events associated with the use of the affected product should be reported to complaints@owens minor.com. 6. RETURN the completed Field Action Response Form to [email protected] as soon as possible even if you have no current product inventory. 7. If credit is requested, please contact the Customer Service team and send email to GM-OMRA_RECALLS@owens minor.com.

    Distribution

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

    Quantity

    452,500 units