BEUDAMED
    FDA Enforcement Class II Ongoing

    The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    Recall: Z-2571-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2571-2025
    Event ID
    97621
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BigTree Sales Inc.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    September 24, 2025
    Initiation Date
    August 29, 2025
    Classification Date
    September 18, 2025
    Address
    11715 Clark St, N/A, Arcadia, CA, 91006-5806, United States

    Description

    The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    Reason

    The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.

    Code Info

    SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020

    Distribution

    U.S.A

    Quantity

    N/A