Medtronic Affinity — Class II medical device recall Z-0693-2020
Terminated recall by Medtronic Perfusion Systems, reported 2019-12-25, distributed in CA. Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial f
| Recall number | Z-0693-2020 |
|---|---|
| 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 | 2019-11-14 |
| Classified | 2019-12-17 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-10-05 |
| Distributed | CA |
| Quantity | 24 units |
| UPC / GTIN / UDI-DI | 20643169858835 |
| Lot numbers | 13316512 |
| Model numbers | 351 |
Product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Reason for recall
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
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-0693-2020. 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.