Gentherm Medical Recalls

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Class I - Dangerous

This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

Nov 22, 2021 Other Medical Devices Nationwide View Details →

Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

Class I - Dangerous

There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.

Jun 17, 2021 Other Medical Devices Nationwide View Details →