Z-0078-2023 Class II Ongoing
FDA device recall Z-0078-2023 was initiated by Olympus Corporation Of The Americas on Sep 16, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 4184 US; 191 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 19, 2022
- Initiation Date
- Sep 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4184 US; 191 OUS
Product Description
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 Pattern
Domestic distribution nationwide. Foreign distribution to Canada and Japan.
Code Information
UDI-DI: 00821925010475 All units are included.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0078-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026