BEUDAMED
    FDA Recall Open, Classified

    Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

    Recall: Z-1758-2026 · Initiated February 11, 2026

    Recall

    Recall Number
    Z-1758-2026
    Event Number
    98415
    Firm
    Burlington Medical, LLC
    FEI Number
    1000120804
    Product Code
    IWO
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 11, 2026
    Posted
    April 2, 2026
    Address
    3 Elmhurst St, Suite 112, Newport News, VA, 23603-1137

    Description

    Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

    Reason

    Potential for attenuation degradation over time, decreasing the lifespan.

    Action

    Burlington Medical notified consignees on about 02/11/2026 via "URGENT - FIELD SAFETY NOTICE (FSN)" letter. Consignees were instructed to ensure all users of the specific Burlington Medical radiation protection garments made aware of this Recall Notice, review inventory for affected units, arrange for the return of those affected units for proper disposal, and complete and return the Recall Response Form. Consignees were also instructed to notify appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold.

    Distribution

    Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

    Quantity

    1,489 units