Z-0766-2023Class II

Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Name: Z-0766-2023 Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Creator: Tomy International Inc.
Published: 2022-12-02
License: https://open.fda.gov/license/

TOMY International / initiated 2022-12-02 / Open, Classified / root cause: manufacturing process

FDA source

Tomy International Inc. began a recall of Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L on 2022-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0766-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-02
Posted: 2022-12-22
Recalling firm: TOMY International
Product: Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Product code: KKO Ring, Teething, Fluid-Filled
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.
Root cause tag: manufacturing process
FDA 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 in commerce: approx 55,000 North America
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
Product codes and lots: UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0766-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0766-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22

Product code KKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)