US Endodontics Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK recall — FDA Z-1114-2025
Due to devices being irradiated above the established specification which my result in package integrity issues.
Overview of recall records associated with US Endodontics, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Due to devices being irradiated above the established specification which my result in package integrity issues.
This page summarizes recall records in which the official source identifies US Endodontics, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.