Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues
US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.
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: FDA Class II recall for package integrity issues caused by over-irradiation specification violation in medical devices used in dental procedures. No reported illnesses or injuries, but compromised package integrity on medical devices poses a risk of harm.
Plain-English summary
US Endodontics, LLC is recalling endodontic files used in root canal treatment, including several product lines: EdgeFile X7, EdgeGlidePath, EdgeOne Fire, EdgeTaper, and EdgeSequel Sapphire. The recall affects 789,729 devices worldwide—47,508 distributed in the United States (Georgia) and 742,221 distributed outside the US.
The recall is due to devices being irradiated above the established manufacturing specification, which may result in package integrity issues. Package integrity is critical for maintaining device sterility and functionality.
The recalled devices have been distributed to dental practices and healthcare facilities in the United States and internationally, including Australia, Canada, and countries in the European Union. Users of these products should verify whether their inventory is affected by checking against the device lot numbers listed by the FDA.
The recalled product
- Product
- Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7…
- Manufacturer
- US Endodontics, LLC
Distribution
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