Device recall
Z-0487-2026: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0487-2026 |
|---|---|
| Recall event | 97702 |
| Product | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B |
| Product code | DTZ |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K241352 |
| FEI number | 1000116158 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database