# FDA recall Z-2092-2021

> **Gentherm Medical, LLC** · Class II · device recall initiated 2021-06-17.

## Product

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

## 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.

## 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

## Key facts

- **Recall number:** Z-2092-2021
- **Recalling firm:** Gentherm Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-17
- **Report date:** 2021-07-28
- **Termination date:** 2023-03-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Blue Ash, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2092-2021

## Citation

> AI Analytics. FDA recall Z-2092-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2092-2021. Source: US FDA. Licensed CC0.

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