Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130 Recalled by LivaNova USA Inc. Due to Incorrect labeling; it was identified that some Datapad...
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
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Quantity: 5 Datapads
Why Was This Recalled?
Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
Where Was This Sold?
This product was distributed to 2 states: CA, NJ
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