FDA recall Z-0078-2023

Olympus Corporation of the Americas · Class II · device

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

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

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