Extra corporeal circuit with bio-active surface — Class II medical device recall Z-2495-2020
Terminated recall by Medtronic Perfusion Systems, reported 2020-07-15, distributed in CA, MI. Affected products failed a sterilization test.
| Recall number | Z-2495-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2018-08-08 |
| Classified | 2020-07-04 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2020-10-06 |
| Distributed | CA, MI |
| Quantity | 10 units |
| Lot numbers | 215729283 |
Product
Extra corporeal circuit with bio-active surface.
Reason for recall
Affected products failed a sterilization test.
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-2495-2020. 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.