Reported Aug 14, 2019 · Terminated

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be…

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?

  • Olympus MAJ-209 Single Use Suction Valves
  • Model Number MAJ-209 Product UsageThis product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models
Lot codes and dates
  • Lot numbers
    • 88H
    • 89H
    • 8XH
    • 8YH
    • 8ZH
    • 91H
Amount recalled
310000

Where it was sold

  • Nationwide

Why it was recalled

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

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

Notice updated Jun 9, 2020 · Data as of Sep 19, 6:12 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.