BEUDAMED
    FDA Enforcement Class II Ongoing

    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

    Recall: Z-1103-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1103-2020
    Event ID
    84707
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fridababy LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    January 27, 2020
    Classification Date
    February 7, 2020
    Address
    82 Ne 26th St Ste 101, Miami, FL, 33137-4406, United States

    Description

    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

    Reason

    FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.

    Code Info

    All Lots

    Distribution

    Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.

    Quantity

    480,144