LivaNova Sorin Connect DPIII KOMPL — Class III medical device recall Z-1119-2020
Terminated recall by LivaNova USA Inc., reported 2020-02-19, distributed in CA, NJ. Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the m
| Recall number | Z-1119-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc., Arvada, CO, United States |
| Recall initiated | 2019-01-28 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2022-01-31 |
| Distributed | CA, NJ |
| Quantity | 5 datapads |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04033817901594 |
| Model numbers | 96-415-130, IPX1 |
Product
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Reason for recall
Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
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-1119-2020. 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.