Device recall
Z-0005-2025: Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software…
FDA device recall · Class I · Zyno Medical LLC
Key facts
| Recall number (Z-number) | Z-0005-2025 |
|---|---|
| Recall event | 95382 |
| Product | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z |
| Product code | FRN |
| Recalling firm | Zyno Medical LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K100705, K130690 |
| FEI number | 3006575795 |
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