CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

Adult ThermoGard¿ Dual Dispersive Electrodes recalled by Conmed

Conmed is recalling Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >, No Cable, distributed in 45 states. The recall was initiated on 18 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBeginning Lot Code 141001X with Ending Lot Code 20150705X.

Quantity recalled4,480 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2596-2016
FDA event ID: 73607
Recalling firm: Conmed, Utica, NY
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2016
FDA classified: 19 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

18 May 2016	Recall initiated by company
19 Aug 2016	Classified by FDA	+93 days
31 Aug 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.

Where it was distributed

Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.

Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Why was it recalled?

A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

Which lots are affected?

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 73607

This product is part of a recall event; the main page for the event is Adult ThermoGard¿ Dual Dispersive Electrodes recalled by Conmed.

Reported	Class	Recall	Company	Reason	Where
31 Aug 2016	CLASS II	Adult ThermoGard¿ Dual Dispersive Electrodes recalled by Conmed	Conmed	Device Malfunction	45 states
31 Aug 2016	CLASS II	Pediatric ThermoGard¿ Dual Dispersive Electrodes recalled by Conmed	Conmed	Device Malfunction	45 states
31 Aug 2016	CLASS II	Adult Dual Dispersive Electrodes (for patients >, use recalled by Conmed	Conmed	Device Malfunction	45 states
31 Aug 2016	CLASS II	Pediatric Dual Dispersive Electrodes (for patients recalled by Conmed	Conmed	Device Malfunction	45 states

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