ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no illnesses or injuries have been reported and the hazard was discovered prior to use, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
ConMed Corporation is recalling 313,190 units of UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT. The recall is due to complaints that some devices had broken through the seal of the sterile pouch, which ConMed confirmed occurred on the affected products.
The affected devices were distributed worldwide, including in the United States, Puerto Rico, and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay. The lot codes for the recalled devices range from 120628X to 120917X.
ConMed has not received any reports that the compromised sterile barrier resulted in illness or injury. The compromised seals were discovered prior to use. Consumers and healthcare providers should stop using the affected devices and contact ConMed for instructions on return or replacement.
The recalled product
- Product
- UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
- Manufacturer
- ConMed Corporation
- Affected units
- 313,190
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 (9)
- Beginning Lot Code 120628X
- 09 represents the month (September)
- 17 represents the day of the month
- and X represents the manufacturing shift code (1
- 2
- 3
- 4
- 5
- 6 or 9)].
Distribution
Part of a larger recall action
This product is one of 20 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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