fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush… — Class II medical device recall Z-1103-2020
Ongoing recall by Fridababy LLC, reported 2020-02-19, distributed nationwide. FridaBaby has been made aware through customer reports that the product is being used outside of the labeled d
| Recall number | Z-1103-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fridababy LLC, Miami, FL, United States |
| Recall initiated | 2020-01-27 |
| Classified | 2020-02-07 |
| Reported by FDA | 2020-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, DO, HN, MX, NI, PE, QA |
| Quantity | 480,144 |
| Reason classes | foreign material, labeling, device malfunction |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1103-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.