CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report

St¿ckert S5 System, S5 Heart-lung machine recalled by Sorin Group USA

Sorin Group USA is recalling St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine, distributed nationwide in the US. The recall was initiated on 25 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670 Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679 Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664 Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656

Quantity recalled5264 Units Worldwide

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2866-2016
FDA event ID: 75036
Recalling firm: Sorin Group USA, Arvada, CO
Classification: Class II
Status: Terminated
Recall initiated: 25 Aug 2016
FDA classified: 21 Sep 2016
Reported: 28 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

25 Aug 2016	Recall initiated by company
21 Sep 2016	Classified by FDA	+27 days
28 Sep 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.

Nationwide Arizona California Colorado Florida Hawaii Kansas Massachusetts North Carolina Texas Utah

Questions about this recall

Is St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine recalled?

Yes. Sorin Group USA recalled St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine on 25 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2866-2016.

Why was it 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.

Which lots are affected?

Item No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670 Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679 Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664 Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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