Device recall
Z-0947-2025: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH…
FDA device recall · Class II · Sklar Instruments
Key facts
| Recall number (Z-number) | Z-0947-2025 |
|---|---|
| Recall event | 95946 |
| Product | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy |
| Product code | HFB |
| 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