Conmed Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (burns) from a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Conmed Corporation is recalling 307,684 units of Adult ThermoGard Dual Dispersive Electrodes (Catalog Number 51-7310). These medical devices are intended for use with electrosurgical generators to disperse electrical current and return it to the generator. The recall covers units with lot codes ranging from 141001X to 20150705X.
The recall was initiated because a version of the dual dispersive electrodes may not be compatible with some electrosurgical generators. This incompatibility places patients at risk for undetected pad lift, which can lead to potential burns. The devices were distributed worldwide, including in the United States and various international markets.
Healthcare facilities and consumers who have these specific electrodes should stop using them immediately. They should contact Conmed Corporation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
- Manufacturer
- Conmed Corporation
- Affected units
- 307,684
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Beginning Lot Code 141001X with Ending Lot Code 20150705X.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Conmed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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