Medical DeviceAug 26, 2026
Gentherm Medical Blanketrol II Model 222S recall — FDA Z-2968-2026
Overheating of the 115V CPU board may cause the device to shut down.
Class IIFDA: OngoingGentherm Medical, LLC
Recall history in this database
Classification mix: Class II: 5.
Medical DeviceAug 26, 2026
Gentherm Medical Blanketrol III, Model 233 recall — FDA Z-2970-2026
Overheating of the 115V CPU board may cause the device to shut down.
Class IIFDA: OngoingGentherm Medical, LLC
Medical DeviceAug 26, 2026
Gentherm Medical Innercool Coolblue Console, Model STx recall — FDA Z-2969-2026
Overheating of the 115V CPU board may cause the device to shut down.
Class IIFDA: OngoingGentherm Medical, LLC
Medical DeviceJan 19, 2022
Gentherm Medical Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number recall — FDA Z-0496-2022
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Class IIFDA: TerminatedGentherm Medical, LLC
Medical DeviceJul 28, 2021
Gentherm Medical Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part recall — FDA Z-2092-2021
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…
Class IIFDA: TerminatedGentherm Medical, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Gentherm Medical, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.