S5 Heart-lung machine — Class II medical device recall Z-0142-2014
Terminated recall by Sorin Group Deutschland GmbH, reported 2013-11-13, distributed in AL, CA, CO, MA, MD, ND, NY, PR…. Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
| Recall number | Z-0142-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group Deutschland GmbH, Munchen, N/A, Germany |
| Recall initiated | 2013-09-24 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-07-10 |
| Distributed | AL, CA, CO, MA, MD, ND, NY, PR, SC, TN, TX, VA, WA, WI |
| Countries outside the US | DE, FI, GB, IT, SE |
| Quantity | 84 |
| Reason classes | device malfunction |
| Serial numbers | 480E1038, 48E00235, 48E00339, 48E00342, 48E01033, 48E01040, 48E01041, 48E01043, 48E01044, 48E01051, 48E01183, 48E01753, 48E01832, 48E01834, 48E02278, 48E02326, 48E02416, 48E02631, 48E02722, 48E02732, 48E02745, 48E02746, 48E02748, 48E02753, 48E02758 and 23 more |
| Model numbers | 48-30/40/50-00 |
Product
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.
Reason for recall
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0142-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.