BEUDAMED
    FDA Enforcement Class II Ongoing

    Burlington Medical, Caps.

    Recall: Z-1760-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1760-2026
    Event ID
    98415
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Burlington Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2026
    Initiation Date
    February 11, 2026
    Classification Date
    April 2, 2026
    Address
    3 Elmhurst St, Suite 112, Newport News, VA, 23603-1137, United States

    Description

    Burlington Medical, Caps.

    Reason

    Potential for attenuation degradation over time, decreasing the lifespan.

    Code Info

    All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD).

    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

    961 units