Olympus recalls Berkeley VC-10 Vacuum Curett: Unlisted accessories may cause serious injury during uterine cavity procedures. Affected units include all models sold with UDI-DI 00821925010475. Contact Olympus for remedy.
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.
Olympus is recalling all Berkeley VC-10 Vacuum Curettage Systems because using unlisted accessories can cause serious injury. This device is used for uterine cavity procedures. The recall affects all units sold with the UDI-DI code 00821925010475.
Using collection canisters not listed in the device's instructions can cause improper fitting with the VC-10. This may lead to serious injuries during uterine cavity procedures. The hazard occurs when unlisted accessories are used without proper compatibility.
Healthcare providers using the Berkeley VC-10 system for uterine procedures are most at risk. Patients undergoing these procedures may also be affected if improper accessories are used.
Check for the model number VC-10 on the device. All units sold with UDI-DI 00821925010475 are affected. The device is used for transcervical aspiration of the uterine cavity.
Review the current Instruction for Use (IFU) to confirm which accessories are approved for the VC-10 system.
Only use collection canisters that are explicitly listed in the updated IFU to avoid serious injury risks.
Olympus is recalling all Berkeley VC-10 Vacuum Curettage Systems because using unlisted accessories can cause serious injury during uterine cavity procedures.
All units sold with UDI-DI 00821925010475 are affected. Check for the model number VC-10 on the device.
Review the updated Instruction for Use (IFU) to confirm which accessories are approved for the VC-10 system. Only use listed accessories to avoid serious injury risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0078-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0078-2023 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
