Class II — US Endodontics, LLC
| Recalling firm | US Endodontics, LLC |
|---|---|
| Registered facility | US Endodontics, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to devices being irradiated above the established specification which my result in package integrity issues. |
| 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 REF: SX70421MM SX70425MM SX70429MM SX70621MM SX70625MM SX70629MM SX7170421RF SX7170425RF SX7170429RF SX7170621RF SX7170625RF SX7170629RF SX7200421RF SX7200425RF SX7200429RF SX7200621RF SX7200625RF SX7200629RF SX7250421RF SX7250425RF SX7250429RF SX7250621RF SX7250625RF SX7250629RF SX7300421RF SX73… |
| Quantity | Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)) |
| Distribution | Worldwide - US Nationwide distribution in the state of GA and the countries of Australia, Canada, the European Union (specifically France, Germany, Italy, Poland, and Spain), and the UK. |
| Initiated | 2025-01-02 |
| Classified | 2025-02-06 |
| Recall number | Z-1114-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — US Endodontics, LLC (Z-1114-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95776/
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