Reported Oct 23, 2019 · Ongoing

Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid…

Olympus Corporation of the Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610

Is this the product you have?

  • Berkeley Disposa-Filter used with Berkeley VC-10
  • Vacuum Curettage System - Product Usagedesigned for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
Lot codes and dates
  • Lot number494604
Amount recalled
1106 boxes (10 filters/box)

Where it was sold

  • Nationwide

Why it was recalled

Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.