Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water Recalled by Maquet Medical Systems USA Due to There is the potential for contaminated water to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Medical Systems USA directly.
Affected Products
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
Quantity: 33
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 10 states: AL, CA, FL, IL, KS, MI, MO, NE, NC, OH
About Maquet Medical Systems USA
Maquet Medical Systems USA has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report