Recall Record

Canton, MA, United States

Tomy International Inc. recalls

1 recall recorded since 2018, most recently on 2 December 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
2 December 2022
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
Initiated
Voluntary: Firm initiated
Recall number
Z-0766-2023

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.