Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
St¿ckert S5 System Recalled by Sorin Group USA, Inc. Due to Sorin/LivaNova is initiating a field correction on the...
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
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
Quantity: 5264 Units Worldwide
Why Was This Recalled?
Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
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