Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CardioQuip Recalled by CardioQuip, LLC Due to There is the potential bacterial including Nontuberculous mycobacterial...
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 CardioQuip, LLC directly.
Affected Products
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Quantity: 1380 units
Why Was This Recalled?
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CardioQuip, LLC
CardioQuip, LLC has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report