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FDASeptember 16, 2022device

Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925010475

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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