Affinity NT Oxygenator — Class II medical device recall Z-0487-2026
Ongoing recall by Medtronic Perfusion Systems, reported 2025-11-19, distributed in AZ, CA, TN. Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet pe
| Recall number | Z-0487-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-11-10 |
| Reported by FDA | 2025-11-19 |
| Distributed | AZ, CA, TN |
| Quantity | 26 units |
| UPC / GTIN / UDI-DI | 00763000187842, 20763000187846 |
| Lot numbers | 231621003 |
| Serial numbers | 5117755016 |
Product
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason for recall
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
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-0487-2026. 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.