Innercool Coolblue Console recall (Gentherm Medical, LLC)
Medical deviceClass IIOngoing
Summary: Gentherm Medical, LLC is recalling Innercool Coolblue Console, Model STx; Thermal regulating system.. Reason: Overheating of the 115V CPU board may cause the device to shut down.
What is being recalled
Innercool Coolblue Console, Model STx; Thermal regulating system.
Why
Overheating of the 115V CPU board may cause the device to shut down.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Puerto Rico)
How to tell if yours is affected
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2969-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 13, 2026 |
| Reported | August 26, 2026 |
| Company | Gentherm Medical, LLC |
| Company location | Blue Ash, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 46 units |
More recalls from Gentherm Medical, LLC · all medical device recalls · recalls from July 2026