Medical device recalls Moderate risk

Fridababy product recalled over possible metal fragments

Recall date
January 27, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Fridababy LLC recalls fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Recall number
Z-1103-2020
FDA classification
Class II
Brand / firm
Fridababy LLC
Sold / distributed
Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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