Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sarns TCM II Recalled by Terumo Cardiovascular Systems Corporation Due to Update to cooler-heater cleaning instructions.
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 Terumo Cardiovascular Systems Corporation directly.
Affected Products
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Quantity: 2393- total for all products
Why Was This Recalled?
Update to cooler-heater cleaning instructions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report