BEUDAMED
    FDA Recall Open, Classified

    See complete list in RES, exceeds character limit. Medline Surgical Gowns

    Recall: Z-2129-2026 · Initiated January 7, 2026

    Recall

    Recall Number
    Z-2129-2026
    Event Number
    98642
    FEI Number
    1417592
    Product Code
    FYA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 7, 2026
    Posted
    May 7, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    See complete list in RES, exceeds character limit. Medline Surgical Gowns

    Reason

    Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    70376042 units