Drug recall
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product…
FDA recall event 97702 · Class II · Medtronic Perfusion Systems
Key facts
| Event ID | 97702 |
|---|---|
| Recall numbers | Z-0487-2026 |
| Recalling firm | Medtronic Perfusion Systems |
| Product type | Devices |
| Products | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. |
| Initiation date | Sep 12, 2025 |
| Report date | Nov 19, 2025 |
| City | Brooklyn Park |
| State | MN |
| Country | United States |
| FEI number | 1000116158 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: