RecallRadar

FDA Device recall Z-0273-2013

S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for proc…

On 2012-11-14 the FDA classified a Class II recall of S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for proc… by Sorin Group Usa, citing sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controll….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0273-2013
ClassificationClass II
Statusterminated
Initiated2012-09-19
Published2012-11-14
Last updated2026-09-13 11:53 UTC
CompanySorin Group Usa
DistributionUS

Product

S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

Reason

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

Identifiers

code_infoSerial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.