BEUDAMED
    FDA Recall Open, Classified

    MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

    Recall: Z-2506-2026 · Initiated May 4, 2026

    Recall

    Recall Number
    Z-2506-2026
    Event Number
    98994
    FEI Number
    1417592
    Product Code
    OKV
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 4, 2026
    Posted
    June 17, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

    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.

    Action

    Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

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

    Quantity

    32438 units