St¿ckert S5 System — Class II medical device recall Z-2866-2016
Terminated recall by Sorin Group USA, Inc., reported 2016-09-28, distributed nationwide. Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for fail
| Recall number | Z-2866-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2016-08-25 |
| Classified | 2016-09-21 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-05-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BH, DE, HU, IN, IT, MY, PE, RU, SK, TH |
| Quantity | 5,264 units |
| Serial numbers | 28E24640, 28E24641, 28E24642, 28E24643, 28E24644, 28E24645, 28E24646, 28E24647, 28E24648, 28E24650, 28E24651, 28E24652, 28E24653, 28E24654, 28E24655, 28E24656, 28E24657, 28E24658, 28E24659, 28E24660, 28E24661, 28E24663, 28E24664, 28E24665, 28E24666 and 13 more |
| Model numbers | 48-30-00, 48-40-00, 48-50-00, 58-00-00 |
Product
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.
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.
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-2866-2016. 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.