Conmed Dual Dispersive Electrodes Recalled for Potential Burn Risk
Conmed Corporation is recalling Adult Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, creating 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 product (potential burn) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Conmed Corporation is recalling 124,333 units of Adult Dual Dispersive Electrodes (Catalog Number 7-382). These electrodes are intended for use with the Birtcher Pad Sensing System on specific Birtcher and CONMED electrosurgical generators, or conventional units with similar contact monitoring systems.
The recall is due to a potential incompatibility between a version of the dual dispersive electrodes and some electrosurgical generators. This incompatibility may result in undetected pad lift, which places patients at risk for a potential burn. The affected units were distributed worldwide, including the United States, Puerto Rico, and various international markets.
Healthcare facilities and users should stop using the affected electrodes and contact Conmed Corporation for further instructions on the recall. The recall covers units with lot codes beginning with 141001X and ending with 20150705X.
The recalled product
- Product
- Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10'…
- Manufacturer
- Conmed Corporation
- Affected units
- 124,333
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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