Device recall
Z-0137-2025: SynchroMed II Infusion Pump. Product Number: 8637-20
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-0137-2025 |
|---|---|
| Recall event | 95419 |
| Product | SynchroMed II Infusion Pump. Product Number: 8637-20 |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2182207 |
At a glance
- None 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