The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1103-2020·Announced 2020-02-19

Fridababy SmileFrida ToothHugger Recalled Due to Potential Metal Exposure

Fridababy LLC is recalling SmileFrida ToothHugger toothbrushes because repeated chewing may cause the plastic head to break, exposing a small internal metal piece.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (exposure to a metal piece) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Fridababy LLC is recalling approximately 480,144 units of the SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush. The recall was initiated after customer reports indicated that the product was being used outside of its labeled directions. Specifically, repeated chewing or biting on the toothbrush has caused deterioration in the outer layer of the brush.

In very rare occasions, this deterioration may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head. The affected products were distributed nationwide and internationally to Canada, Mexico, Nicaragua, the Dominican Republic, Honduras, Chile, Peru, and Qatar. No US governmental consignees were involved.

Consumers should stop using the product immediately. The recall covers all lots of the SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush.

The recalled product

Product
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Manufacturer
Fridababy LLC
Category
Consumer Product — Baby/Infant Products
Hazard
Affected units
480,144

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

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