Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
S5 Heart-lung machine Recalled by Sorin Group Deutschland GmbH Due to Sorin Group is recalling certain models of S5...
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 Deutschland GmbH directly.
Affected Products
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Quantity: 84
Why Was This Recalled?
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Where Was This Sold?
This product was distributed to 13 states: AL, CA, CO, MD, MA, NY, ND, SC, TN, TX, VA, WA, WI
About Sorin Group Deutschland GmbH
Sorin Group Deutschland GmbH has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report