Device recall
Z-1577-2026: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF…
FDA device recall · Class I · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1577-2026 |
|---|---|
| Recall event | 98464 |
| Product | 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B |
| Product code | DYB |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K043438 |
| FEI number | 1721504 |
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