US Endodontics, LLC is recalling 789,729 rotary and reciprocating endodontic files, including the Brasseler ESR and various Edge brands like EdgeFile X7, EdgeOne Fire, and EdgeTaper. The recall was initiated because these dental tools were exposed to high levels of radiation during the sterilization process, which can weaken the packaging and compromise its integrity. If the sterile packaging is damaged, the files may no longer be sterile, posing a risk of infection to patients during root canal procedures. There have been no reported injuries related to this issue, but users are advised to stop using affected lots immediately and contact their distributor.
The high levels of radiation used in sterilization may lead to brittle or damaged packaging. If the package seal or material fails, bacteria can contaminate the previously sterile files, potentially leading to post-operative infections or surgical complications for patients.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.