FDA Device recall Z-0078-2023
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Berkeley VC-10 Vacuum Curettage System, Model No. VC-10 by Olympus, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0078-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-16 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Reason
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 collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.
Identifiers
| code_info | UDI-DI: 00821925010475 All units are included. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2023%22
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