S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5… — Class II medical device recall Z-0856-2014
Terminated recall by Sorin Group Deutschland GmbH, reported 2014-02-05, distributed nationwide. Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to repo
| Recall number | Z-0856-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group Deutschland GmbH, Munchen, Germany |
| Recall initiated | 2013-12-04 |
| Classified | 2014-01-28 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 323 |
| Model numbers | 10-80-00, 10-85-00, 28-95-8S, 28-9S-80, S8-00-00 |
Product
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Reason for recall
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
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-0856-2014. 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.