Gentherm Medical, LLC Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Brand
Gentherm Medical, LLC
Lot Codes / Batch Numbers
All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
Products Sold
All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
Gentherm Medical, LLC is recalling Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or due to There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including N. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 6/17/2021, Gentherm issued Urgent Medical Device Recall notices and response forms to customers via courier service. Instructions to Customers: 1) Immediately examine your inventory, access updated manuals and ensure obsolete manuals are removed from service. 2) Updated manuals may be accessed via www.gentherm.com or physicial copies may be requested from Gentherm Medical, LLC at 1-888-437-5608. 3) Ensure that all users are informed of the contents of this letter. 4) If you have further distributed this product, please provide those accounts with a copy of this notice. 5) Complete and return the customer response form via email to FA2021-004@gentherm.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026