# FDA recall Z-0766-2023

> **Tomy International Inc.** · Class II · device recall initiated 2022-12-02.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.

## Key facts

- **Recall number:** Z-0766-2023
- **Recalling firm:** Tomy International Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-02
- **Report date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0766-2023

## Citation

> AI Analytics. FDA recall Z-0766-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0766-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
