Class II — Tomy International Inc.
| Recalling firm | TOMY International, Inc. |
|---|---|
| Registered facility | TOMY International, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L |
| Quantity | approx 55,000 North America |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic. |
| Initiated | 2022-12-02 |
| Classified | 2022-12-22 |
| Recall number | Z-0766-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tomy International Inc. (Z-0766-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91177/
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