Tomy International Inc.: Medical Device Recall in 2022 - (Recall #: Z-0766-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 2, 2022

Date Posted: December 28, 2022

Recall Number: Z-0766-2023

Event ID: 91177

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.

Status: Ongoing

Product Quantity: approx 55,000 North America

Code Information:

UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated