FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
- Recall number
- Z-0078-2023
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
- Status
- Open, Classified
- Initiated
- 2022-09-16
- Posted
- 2022-10-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling design
- Action
- On September 16, 2022, the recalling firm notified affected customers through "URGENT Medical Device Field Corrective Action" letters. Customers were informed that the following new warning will be added to the IFU: Do not use replacement parts or accessories that are not compatible with the VC-10 system. Use of noncompatible accessories could lead to reduced system functionality and/or patient injury such as perforation, bleeding, and may require additional intervention. Refer to Section 11 for all accessories compatible with the VC-10 system. Customers should notify their users about risks associated with using non-compatible collection canisters and/or accessories and remind them to follow the list of compatible accessories outlined in Section 11 of the IFU. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. " Go to https://olympusamerica.com/recall. Enter the recall number 0414 " Enter your name and mailing address. Olympus will supply a copy of the revised IFU at a later date If you have distributed these devices outside your facility, please notify your customers of this matter immediately. If you have any questions, call (647) 999-3203 or email: Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
- Quantity
- 4184 US; 191 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada and Japan.
- Lot, serial or model codes
- UDI-DI: 00821925010475 All units are included.
- 510(k) numbers
- ["K171440"]
- PMA numbers
- not on file
- Product code
- HHK
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28