[Recalled] 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 CUR
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Sklar Instruments |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0943-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 December 2024 |
| EAN / barcode | 50649111492899 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Reports of various packaging issues that may result in a breach of the sterile barrier.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Sklar Instruments
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.