Drug recall
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
FDA recall event 90876 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 90876 |
|---|---|
| Recall numbers | Z-0078-2023 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of… |
| Initiation date | Sep 16, 2022 |
| Report date | Oct 19, 2022 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: