Hemotherm CE Dual Reservoir Cooler/Heater — Class II medical device recall Z-2092-2021
Terminated recall by Gentherm Medical, LLC, reported 2021-07-28, distributed nationwide. There is a potential risk of device contamination and patient infection associated with the device because of
| Recall number | Z-2092-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentherm Medical, LLC, Blue Ash, OH, United States |
| Recall initiated | 2021-06-17 |
| Classified | 2021-07-19 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2023-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BD, CH, CL, CO, FR, GT, HU, ID, IL, IN, IT, KR, NG, NP, PH, PK, RO, SA, SG, TH, TR, TW, ZA |
| Serial numbers | 092-10011CE, 212-11499CE |
| Model numbers | 115V, 400CE, 86022 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2092-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.