# FDA recall Z-0078-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2022-09-16.

## 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.

## Distribution

Domestic distribution nationwide. Foreign distribution to Canada and Japan.

## Key facts

- **Recall number:** Z-0078-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-16
- **Report date:** 2022-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2023

## Citation

> AI Analytics. FDA recall Z-0078-2023. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0078-2023. Source: US FDA. Licensed CC0.

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