Class II — Gentherm Medical, LLC
| Recalling firm | Gentherm Medical LLC |
|---|---|
| Registered facility | Jiangmen Dacheng Medical Equipment Co., Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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) |
| Distribution | 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 |
| Initiated | 2021-06-17 |
| Classified | 2021-07-19 |
| Terminated | 2023-03-01 |
| Recall number | Z-2092-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Gentherm Medical, LLC (Z-2092-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88187/
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