Device recall
Z-0943-2025: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE…
FDA device recall · Class II · Sklar Instruments
Key facts
| Recall number (Z-number) | Z-0943-2025 |
|---|---|
| Recall event | 95946 |
| Product | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy |
| Product code | HCY |
| Recalling firm | Sklar Instruments |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K772229, K802458 |
| 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