Gentherm Medical, LLC: Medical Device Recall in 2021 - (Recall #: Z-2092-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 17, 2021

Date Posted: July 28, 2021

Recall Number: Z-2092-2021

Event ID: 88187

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1448 devices (1010 US; 438 OUS)

Code Information:

All units in service life Serial Numbers: 092-10011CE tot 212-11499CE

Distribution Pattern:

Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE

Voluntary or Mandated:

Voluntary: Firm initiated