Lamaze Chill Teether — Class II medical device recall Z-0766-2023
Ongoing recall by Tomy International Inc., reported 2022-12-28, distributed nationwide. Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the devi
| Recall number | Z-0766-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tomy International Inc., Canton, MA, United States |
| Recall initiated | 2022-12-02 |
| Classified | 2022-12-22 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DO |
| Quantity | 55,000 north |
| Reason classes | microbial contamination |
| Lot numbers | E1920ALP01, K1920ALP01 |
| Model numbers | Y5288L |
Product
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Reason for recall
Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.
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-0766-2023. 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.