Reported Oct 14, 2015 · Terminated

MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument…

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 · PO Box 610 · Center Valley, PA · 18034-8229

Is this the product you have?

  • MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
Lot codes and dates
  • ModelsPart number K10016901 is a package of 10 pieces, Part number K10007072 is a package
  • of 100 pieces Part number K10016901
    • lot numbers 20115441
    • 20116536
  • Part number K10007072
    • lot numbers 20115441
    • 20116536
Amount recalled
31060

Where it was sold

  • Nationwide

Why it was recalled

small puncture marks in a sterile package for an accessory to an Olympus device

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 Mar 13, 2017 · Data as of Sep 19, 6:01 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.