BEUDAMED
    FDA Recall Open, Classified

    Material Processing Laser Products

    Recall: Z-0888-2026 · Initiated September 30, 2025

    Recall

    Recall Number
    Z-0888-2026
    Event Number
    98118
    Firm
    SHENZHEN ATOMSTACK TECHNOLOGIES
    FEI Number
    3021692431
    Product Code
    RFE
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    September 30, 2025
    Posted
    December 31, 2025
    Address
    3 Baolong 6 Rd, Guangdong, China

    Description

    Material Processing Laser Products

    Reason

    Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)

    Action

    CAP letter to be sent to customers.

    Distribution

    U.S.