Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CritiCool Recalled by Belmont Instrument Corporation Due to Premature pump failure may lead to the device...
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 Belmont Instrument Corporation directly.
Affected Products
CritiCool, thermoregulation device
Quantity: 158 (US); 803 (OUS)
Why Was This Recalled?
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Belmont Instrument Corporation
Belmont Instrument Corporation has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report