# FDA recall Z-1103-2020

> **Fridababy LLC** · Class II · device recall initiated 2020-01-27.

## Product

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

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1103-2020
- **Recalling firm:** Fridababy LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-01-27
- **Report date:** 2020-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2020

## Citation

> AI Analytics. FDA recall Z-1103-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1103-2020. Source: US FDA. Licensed CC0.

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