Use cautionMedical device recall · FDA · Published July 14, 2021
Maquet Heater Cooler Unit HCU 30: Risk of Bacterial Contamination
Maquet recalls HCU 30 Heater Cooler Units due to potential bacterial contamination, including Mycobacteria. Affected units have specific model numbers and serial numbers. Consumers should contact Maquet for details.
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Take action
Contact the company
📍Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094
“Maquet Heater Cooler Unit HCU 30: Risk of Bacterial Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62207-maquet-heater-cooler-unit-hcu-30-risk-of-bacterial-contamination. Based on FDA recall #Z-2140-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2140-2021%22&limit=1).
The FDA announced on July 14, 2021, that Maquet Medical Systems USA is recalling the Heater Cooler Unit (HCU 30) due to the potential for contaminated water to enter device circuits. This contamination poses a risk of bacterial infection, including Mycobacteria species.
How to tell if you have it
Brand: Maquet Medical Systems
Product: Heater Cooler Unit (HCU 30)
Model Numbers: 704629 I 70103.4371, 705501 I 70103.4653, 939001 I 70102.8718
Units affected: 33
The hazard
The device supplies temperature-controlled water for cardioplegia heat exchangers and blood heat exchangers in extracorporeal circulation. There is a potential for contaminated water to enter parts of the Heater-Cooler Unit circuits, creating a risk of bacterial contamination including Mycobacteria species.
Context
GovInfoNow's records show Maquet Medical Systems USA has had 14 other recalls since February 18, 2022. Recent brand recalls include the April 15, 2024 Maquet Cardiohelp-i System Recall for excessive patient leakage current risk and the January 16, 2024 Maquet BEQ-HLS 7050 Recall for compromised sterile barrier risk. Other recent recalls of similar products include the June 24, 2026 ICU Medical Hotline Fluid Warming Set Recall and the August 10, 2026 Cardinal Health Presource Convenience Kits Recall.
How to tell if you have this one
Check for model numbers 704629, 705501, or 939001 on the base unit. All units with serial numbers are affected. The device is used in hospitals for medical procedures.
Brand
Maquet Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Maquet
Reach out to Maquet Medical Systems USA for specific instructions on how to handle the recalled unit.
Where it went and when
Where it was distributed
Distributed in 10 states.
Listed by the agency
Not listed
FDA distribution: “Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-2140-2021 (July 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2140-2021 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.