BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

    Recall: Z-1889-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-1889-2026
    Event Number
    98601
    FEI Number
    1417592
    Product Code
    KKX
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    February 27, 2026
    Posted
    April 17, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

    Reason

    Unapproved design changes to the products outside of the 510(k) clearance.

    Action

    On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

    Quantity

    270,311 total