Reported Dec 30, 2020 · Terminated

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED…

Ga Health Company Limited

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: GA HEALTH COMPANY LIMITED · Unit 18, 21/F · Shatin N.T., N/A · N/A

Is this the product you have?

  • STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/
  • Biopsy-Valve) DISTRIBUTED BYKEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE
  • MN 55344 / USA Product CodeEN10229
Lot codes and dates
  • Lot Numbers
    • 19121831
    • 20032007
  • Unit UDI04897106951093
  • Box UDI14897106951090
  • Carton Box UDI24897106951097
Amount recalled
12,800 units

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

Why it was recalled

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 3, 2021 · Data as of Sep 19, 7:36 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.