Manual Toothbrush — Class II medical device recall Z-1213-2015
Terminated recall by Norwex Usa Inc, reported 2015-03-04, distributed nationwide. The toothbrush head can potentially disengage from the handle.
| Recall number | Z-1213-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Norwex Usa Inc, Addison, TX, United States |
| Recall initiated | 2015-02-03 |
| Classified | 2015-02-26 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2016-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 35,214 |
| Model numbers | 354075, 354076, 354077, 354078 |
Product
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use.
Reason for recall
The toothbrush head can potentially disengage from the handle.
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-1213-2015. 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.