🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 16, 2022 Olympus Corporation of the Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00821925010475 All units are included.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Olympus Corporation of the Americas
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI-DI: 00821925010475 All units are included.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0078-2023

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