BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599

    Recall: Z-1881-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-1881-2026
    Event Number
    98601
    FEI Number
    1417592
    Product Code
    FDE
    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 BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599

    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