BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262

    Recall: Z-1880-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-1880-2026
    Event Number
    98601
    FEI Number
    1417592
    Product Code
    OGR
    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 MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262

    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