Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company Due to Warnings statements have been added- exceeding 40 degree...
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
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Quantity: 5291
Why Was This Recalled?
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
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