FDA Medical Device Recalls (openFDA)
Tomy International Inc.: Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
- Recall number
- Z-0766-2023
- Recalling firm
- Tomy International Inc.
- Product
- Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
- Status
- Open, Classified
- Initiated
- 2022-12-02
- Posted
- 2022-12-22
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- On 12/2/2022, the firm notified customers with Medical Device Recall letters. Customers were instructed to identify any affected product on hand and dispose of all affected products. The firm may provide payment credits to customers for disposed units. Customers should notify downstream accounts if affected lots were distributed to third parties. Customers/Retailers were provided with recall posters to post in a conspicuous location for consumers, to ensure that anyone who purchased a product from the affected lots is notified that they should stop using and dispose of the product. Consumers should immediately stop using affected product and dispose of it in the trash. Do not return the item to the store. Production code can be found directly on the back of the packaging and on the product itself. For more information, consumers can contact TOMY International, Inc. by telephone at 1-866-725- 4407 from 8:00 a.m. and 4:00 p.m. CT Monday through Friday or visit https://recall.tomy.com/chillteether.html (web URL updated 9/8/23).
- Quantity
- approx 55,000 North America
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
- Lot, serial or model codes
- UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KKO
- Firm FEI
- 1217805
- Firm city
- Canton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28