CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Lamaze Chill Teether, Fluid-Filled Teething Ring recalled
Tomy International is recalling Lamaze Chill Teether, Fluid-Filled Teething Ring, distributed nationwide in the US. The recall was initiated on 2 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0766-2023
- FDA event ID
- 91177
- Recalling firm
- Tomy International, Canton, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Dec 2022
- FDA classified
- 22 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Dec 2022 | Recall initiated by company | |
| 22 Dec 2022 | Classified by FDA | +20 days |
| 28 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
Questions about this recall
Is Lamaze Chill Teether, Fluid-Filled Teething Ring recalled?
Yes. Tomy International recalled Lamaze Chill Teether, Fluid-Filled Teething Ring on 2 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-0766-2023.
Why was it recalled?
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.
Which lots are affected?
UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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