Gentherm Medical Recalls Blanketrol III Thermal Regulating Systems
Gentherm Medical is recalling 9,714 Blanketrol III thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Gentherm Medical, LLC is recalling 9,714 units of the Blanketrol III, Model 233 thermal regulating system. The recall is due to a defect where overheating of the 115V CPU board may cause the device to shut down.
The affected units were distributed worldwide, including US nationwide distribution in Puerto Rico, and in Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago. The specific units are identified by UDI codes 1061303186102, 1061303186107, 1061303186139, 1061303187107, and 1061303187307, and serial numbers ranging from 131-2-00580 through 262-3-20277.
Healthcare facilities and users should check their inventory for these specific serial numbers and UDI codes. If a unit matches the recalled description, it should be removed from service and the recalling firm contacted for instructions.
The recalled product
- Product
- Blanketrol III, Model 233; Thermal regulating system.
- Manufacturer
- Gentherm Medical, LLC
- Affected units
- 9,714
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI: 1061303186102
- UDI: 1061303186107
- UDI: 1061303186139
- UDI: 1061303187107
- UDI: 1061303187307
- Serial Numbers:131-2-00580 through 262-3-20277
Distribution
Related recalls
Same manufacturer · Gentherm Medical, LLC
See all →- ModerateGentherm Medical Recalls Blanketrol II Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- HighGentherm Medical Recalls Innercool Coolblue Console Due to Overheating Risk
FDA (Devices) · 2026-08-26
- ModerateElectri-Cool II Portable Cold Therapy Unit Recalled for Operating Instruction Labeling Update
FDA (Devices) · 2022-01-19
- HighBlood heater-cooler devices recalled for water contamination and infection risk
FDA (Devices) · 2021-07-28
Same hazard · overheating
See all →- Severe
- SevereTherabody Theragun G4 PRO Charger Recalled for Fire Risk
FDA (Devices) · 2026-08-12
- SevereOXOS Medical Recalls MC2 Portable X-Ray Systems Over Circuit Board Overheating
FDA (Devices) · 2026-08-12
- High
- Critical