Device recall
Z-0912-2026: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
FDA device recall · Class II · Nipro Medical Corporation
Key facts
| Recall number (Z-number) | Z-0912-2026 |
|---|---|
| Recall event | 97914 |
| Product | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only |
| Product code | KDI |
| Recalling firm | Nipro Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K182940 |
| FEI number | 1000132332 |
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