Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sorin Stockert Heater-Cooler 3T Recalled by Sorin Group USA, Inc. Due to Potential colonization of organisms, including Mycobacteria, in Sorin...
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 Sorin Group USA, Inc. directly.
Affected Products
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Quantity: 1755
Why Was This Recalled?
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sorin Group USA, Inc.
Sorin Group USA, Inc. has 52 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report