Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SORIN Heater-Cooler System 3T Recalled by LivaNova USA Inc. Due to For six units, the post-deep cleaning (DC) water...
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 LivaNova USA Inc. directly.
Affected Products
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Quantity: 6 devices
Why Was This Recalled?
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Where Was This Sold?
This product was distributed to 3 states: IN, MO, OH
About LivaNova USA Inc.
LivaNova USA Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report