Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hemotherm CE Dual Reservoir Cooler/Heater Recalled by Gentherm Medical, LLC Due to There is a potential risk of device contamination...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Gentherm Medical, LLC directly.
Affected Products
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Quantity: 1448 devices (1010 US; 438 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Gentherm Medical, LLC
Gentherm Medical, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report