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Recall Observatory FDA recall evidence

Device product

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

Z-1103-2020

January 27, 2020

Class II

Product summary

Firm
Fridababy LLC
Event
Event 84707
Status
Ongoing
Classification
Class II
Quantity
480,144
Official record key
device-enforcement:Z-1103-2020

Official wording

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 information: All Lots

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    metal piece