Berkeley VC-10 Vacuum Curettage System — Class II medical device recall Z-0078-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2022-10-19, distributed nationwide. Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which
| Recall number | Z-0078-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2022-09-16 |
| Classified | 2022-10-11 |
| Reported by FDA | 2022-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| UPC / GTIN / UDI-DI | 00821925010475 |
| Model numbers | VC-10 |
Product
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0078-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.