Z-0078-2023Class II

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

Name: Z-0078-2023 Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity
Creator: Olympus Corporation of the Americas
Published: 2022-09-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-09-16 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity on 2022-09-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0078-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-16
Posted: 2022-10-12
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.
Product code: HHK Curette, Suction, Endometrial (And Accessories)
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.
Root cause tag: labeling and UDI
FDA 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: [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 4184 US; 191 OUS
Distribution: Domestic distribution nationwide. Foreign distribution to Canada and Japan.
Product codes and lots: UDI-DI: 00821925010475 All units are included.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0078-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0078-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-11

Product code HHK

K171440Class IIBerkeley VC-10 Vacuum Curettage SystemGyrus Acmi / cleared 2017-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)