BEUDAMED
    FDA Enforcement Class II Ongoing

    The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

    Recall: Z-1807-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1807-2026
    Event ID
    98747
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Uvlizer c/o RAIS INTERNATIONAL LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    April 29, 2026
    Initiation Date
    March 6, 2026
    Classification Date
    April 17, 2026
    Address
    16192 Coastal Hwy, N/A, Lewes, DE, 19958-3608, United States

    Description

    The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

    Reason

    In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.

    Code Info

    None provided.

    Distribution

    U.S.

    Quantity

    480,000