Gentherm Medical, Llc: System, Thermal Regulating
Recall Summary Gentherm Medical is recalling three thermal regulating system models (Blanketrol II Model 222S, Blanketrol III Model 233, and Innercool CoolBlue Model STx) due to potential overheating of internal circuit boards that could cause the devices to shut down unexpectedly. The affected products were distributed worldwide, including throughout the United States and multiple countries in the Americas, Middle East, and Asia. This is a Class II recall, indicating a situation where use of the product may cause serious adverse health consequences or death.
- Recalling firm
- Gentherm Medical, LLC
- Product
- Blanketrol II Model 222S; Thermal regulating system.
- Reason
- Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/08a84650-673e-4c66-ac21-0b36703f9610