TemporaryFDAOngoing
Can cause harm that is usually temporary.
Blanketrol II Model 222S; Thermal regulating system.
Check the device or its packaging for
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
- Why
- Overheating of the 115V CPU board may cause the device to shut down.
- Distributed
- Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.
- Company
- Gentherm Medical, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2968-2026 · retrieved 14 August 2026
Read the official notice