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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of potential burns, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury reports or risk).
Plain-English summary
Conmed Corporation is recalling 4,480 units of Adult ThermoGard Dual Dispersive Electrodes (Catalog Number 51-7410). These devices are intended for patients weighing more than 15 kg and are used for the dispersion and return to the electrosurgical 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 a potential burn. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including the United States (all states and Puerto Rico) and numerous international countries such as Australia, Canada, China, France, Japan, and the United Kingdom. Healthcare providers and facilities that have used or possess these specific lot codes should stop using the devices and contact Conmed Corporation for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Conmed Corporation
- Affected units
- 4,480
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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