Device recall
Z-1128-2026: Merit Medical, Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1128-2026 |
|---|---|
| Recall event | 98139 |
| Product | Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B |
| Product code | OEQ |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1721504 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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