Reported Dec 11, 2019 · Terminated

Quantam 2000 Electrosurgical Generator, Part number 909075-05.

CooperSurgical, 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: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

    • Quantam 2000 Electrosurgical Generator
    • Part number 909075-05
Lot codes and dates
  • Serial numbers
    • 2015120001-2015120030
    • 2016030001-2016030030
    • 2016040001-2016040018
    • 2016050001-2016050030
    • 2016060001-2016060020
    • 2016070001-2016070040
    • 2016080001-2016080006
    • 2016090001-2016090016
    • 2016110001-2016110008
    • 2016120001-2016120006
    • 2017010001-2017010008
    • 2017020001-2017020009
    • 2017030001-2017030011
    • 2017040001-2017040008
    • 2017060001-2017060015
    • 2017080002
    • 2017080006
    • 2017080010
Amount recalled
110

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.

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 30, 2020 · Data as of Sep 19, 6:07 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.