Device recall
Z-0946-2025: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR…
FDA device recall · Class II · Sklar Instruments
Key facts
| Recall number (Z-number) | Z-0946-2025 |
|---|---|
| Recall event | 95946 |
| Product | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL… |
| Product code | HDQ |
| Recalling firm | Sklar Instruments |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K772229 |
| FEI number | 2523865 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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