Recall record at a glance
| Official record | Z-1103-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Fridababy LLC |
| Report date | Feb 19, 2020 |
| Recall initiation date | Jan 27, 2020 |
| Quantity | 480,144 |
| Location | Miami, FL, United States |
Official product description
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Why the product 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.
Distribution information
Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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