BEUDAMED
    FDA Enforcement Class II Ongoing

    OttLite Rechargeable UVC Disinfecting Wand

    Recall: Z-1473-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1473-2023
    Event ID
    92043
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ottlite TEchnologies, Inc.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 10, 2023
    Initiation Date
    November 17, 2022
    Classification Date
    May 1, 2023
    Address
    1715 N West Shore Blvd Ste 950, Tampa, FL, 33607-3920, United States

    Description

    OttLite Rechargeable UVC Disinfecting Wand

    Reason

    Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exposure limits recommended by the International Commission on Non-ionizing Radiation Protection (ICNIRP). The emissions are hazardous to users and others in the vicinity.

    Code Info

    model: UV10002M

    Distribution

    US Natioonwide Distribution

    Quantity

    7376 units