BEUDAMED
    FDA Recall Open, Classified

    Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

    Recall: Z-1848-2026 · Initiated February 25, 2026

    Recall

    Recall Number
    Z-1848-2026
    Event Number
    98599
    FEI Number
    1417592
    Product Code
    OKV
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    February 25, 2026
    Posted
    April 17, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

    Reason

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Action

    An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or [email protected]. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter

    Distribution

    US Nationwide distribution.

    Quantity

    12 units