CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

S5 Heart-lung machine, Stockert S5 System recalled

Sorin Group Deutschl is recalling S5 Heart-lung machine, Stockert S5 System, distributed in 14 states. The recall was initiated on 24 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801

Quantity recalled84

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-0142-2014
FDA event ID: 66464
Recalling firm: Sorin Group Deutschl, Munchen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 24 Sep 2013
FDA classified: 4 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Sep 2013	Recall initiated by company
4 Nov 2013	Classified by FDA	+41 days
13 Nov 2013	Published in enforcement report	+9 days

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

Reason for recall

Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

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

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.

Where it was distributed

Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.

Alabama California Colorado Massachusetts Maryland North Dakota New York Puerto Rico South Carolina Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

Which lots are affected?

Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801

Where was it sold?

Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.

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

More recalls from Sorin Group Deutschl

All 4

Reported	Class	Recall	Company	Reason	Where
31 Jan 2018Device	CLASS II	CP5 Centrifugal Pump, made up of the drive unit recalled	Sorin Group Deutschl	Device Malfunction	N/A
5 Feb 2014Device	CLASS II	CP5 centrifugal pump system recalled by Sorin Group Deutschland	Sorin Group Deutschl	Device Malfunction	Nationwide
5 Feb 2014Device	CLASS II	S5/C5 Heart-lung machine recalled by Sorin Group Deutschland	Sorin Group Deutschl	Device Malfunction	Nationwide

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