Reported Aug 25, 2021 · Terminated

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments…

Ethicon Endo-Surgery 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: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803

Is this the product you have?

  • ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures
  • Product CodePSEE60A
Lot codes and dates
  • Lot U94V47 Exp Date
    • July 31
    • 2023
  • GTIN10705036014607
Amount recalled
763 eaches

Where it was sold

Why it was recalled

Mislabeled: Labeled on the package as 60mm contains 45mm devices

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 Sep 14, 2022 · Data as of Sep 19, 6:59 PM UTC

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