BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.

    Recall: Z-2479-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2479-2026
    Event ID
    98994
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2026
    Initiation Date
    May 4, 2026
    Classification Date
    June 17, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.

    Reason

    During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

    Code Info

    1. DYND13508, UDI/DI 10080196031139 (each), 20080196031136 (case); 2. DYND13510, UDI/DI 10080196726462 (each), 40080196726463 (case); 3. DYND13512, UDI/DI 10080196031177 (each), 40080196031178 (case); 4. DYND13514, UDI/DI 10080196726219 (each), 40080196726210 (case); 5. DYND13515, UDI/DI 10080196031214 (each), 40080196031215 (case); 6. DYND13516, UDI/DI 10080196031221 (each), 40080196031222 (case); 7. DYND13518, UDI/DI 10080196031245 (each), 40080196031246 (case); 8. DYND13520, UDI/DI 10080196031252 (each), 40080196031253 (case); 9. DYND13522, UDI/DI 10080196061259 (each), 40080196061250 (case); 10. DYND13614, UDI/DI 10080196031276 (each), 30080196031270 (case); 11. DYND13616, UDI/DI 10888277720879 (each), 20888277720876 (case); ALL LOTS

    Distribution

    Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

    Quantity

    2237471 units