Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hemotherm 400CE Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company Due to Potential for membrane (control panel) switch errors leading...
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 Cincinnati Sub-Zero Products LLC, a Gentherm Company directly.
Affected Products
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Quantity: 270 units
Why Was This Recalled?
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cincinnati Sub-Zero Products LLC, a Gentherm Company
Cincinnati Sub-Zero Products LLC, a Gentherm Company has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report