Reported Mar 28, 2018 · Terminated

GENICON EZEE Retrieval, sterile, Rx only.

Genicon, Inc.

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: Genicon, Inc. · 6869 Stapoint Ct Ste 112 · Winter Park, FL · 32792-6603

Is this the product you have?

  • GENICON EZEE Retrieval, sterile, Rx only.
Lot codes and dates
    • Catalog No. 550-000-000
    • Lot No. I8095/2017-11-08
    • I8162-2018-01-09
    • I8162/2020-01-09
  • UDI00877972005223
Amount recalled
2,967 units

Where it was sold

Why it was recalled

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

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 May 18, 2020 · Data as of Sep 19, 6:14 PM UTC

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