Use cautionMedical device recall · FDA · Published June 17, 2021
Gentherm Hemotherm 400CE Cooler/Heater Recall: Risk of Patient Infection
Gentherm recalls Hemotherm 400CE blood cooler/heater units due to potential contamination and infection risks during surgery. Affected units have serial numbers 092-10011CE to 212-11499CE.
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.
“Gentherm Hemotherm 400CE Cooler/Heater Recall: Risk of Patient Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62333-gentherm-hemotherm-400ce-cooler-heater-recall-risk-of-patient-infection. Based on FDA recall #Z-2092-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2092-2021%22&limit=1).
The FDA announced on June 17, 2021, that Gentherm Medical, LLC voluntarily recalled the Hemotherm CE Dual Reservoir Cooler/Heater due to a potential risk of device contamination and patient infection. The agency stated that organisms could grow in the water systems and aerosolize during surgery.
How to tell if you have it
Brand: Gentherm
Product: Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model
Part no.: 86022
Serial Numbers: 092-10011CE to 212-11499CE
The hazard
According to the FDA, there is a potential risk of device contamination and patient infection because organisms, including Nontuberculous mycobacteria (NTM), can grow in the water systems. Contaminated water from the device has the potential to aerosolize into the operating room during surgery, which could lead to patient infection.
Context
GovInfoNow's records show Gentherm Medical, LLC has issued two other recalls since November 22, 2021. On July 13, 2026, the company recalled the Blanketrol III Model 233 Thermal Regulator due to an overheating risk. On November 22, 2021, Gentherm issued a labeling update for the Electri-Cool II Cold Therapy Unit. Other recent recalls of similar products include Spectrum Medical's Quantum PureFlow Heat Exchangers (July 17, 2026), ICU Medical's Hotline Fluid Warming Set (June 24, 2026), and Philips' Allura Xper FD10C Medical System (December 15, 2025).
How to tell if you have this one
Check the serial number on the device, which ranges from 092-10011CE to 212-11499CE. The device is used to cool or warm blood during heart surgery procedures.
Brand
Gentherm
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for the serial number on the device, which should be between 092-10011CE and 212-11499CE.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2092-2021 (June 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2092-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.