FDA recall, , Moderate risk
Blanketrol II, Blanketrol III, and Innercool Coolblue Console
The Blanketrol II thermal regulating system may shut down due to overheating of its 115V CPU board.
Summary by Recall Canary from the FDA notice
What happened
Gentherm Medical, LLC, of Blue Ash, Ohio, recalled the Innercool Coolblue Console Model STx, Blanketrol III Model 233, and Blanketrol II Model 222S thermal regulating systems because overheating on 115V CPU boards may cause the device to shut down. The recall began July 13, 2026, and was added to the FDA's Enforcement Report on August 14, 2026.
The products were distributed nationwide, including Puerto Rico, and to Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Innercool Coolblue Console, Model STx; Thermal regulating system.
- UDI-DI
- 1061303186165
Blanketrol III, Model 233; Thermal regulating system.
- UDI-DI
- 1061303186102
- 1061303186107
- 1061303186139
- 1061303187107
- 1061303187307
Blanketrol II Model 222S; Thermal regulating system.
- UDI-DI
- 1061303186165
Recall details
- Company began the recall
- Sold in
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, LLCBlue Ash, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99478
- Recall numbers
- Z-2968-2026 to Z-2970-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
