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Gentherm Medical, LLC FDA Recalls
5 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Blanketrol III, Model 233; Thermal regulating system.Class IIJul 13, 2026Overheating of the 115V CPU board may cause the device to sh |
| Blanketrol II Model 222S; Thermal regulating system.Class IIJul 13, 2026Overheating of the 115V CPU board may cause the device to sh |
| Innercool Coolblue Console, Model STx; Thermal regulating system.Class IIJul 13, 2026Overheating of the 115V CPU board may cause the device to sh |
| Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193Class IINov 22, 2021This recall has been initiated to provide a labeling update |
| Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cClass IIJun 17, 2021There is a potential risk of device contamination and patien |