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 SX7300425RF SX7300429RF SX7300621RF SX7300625RF SX7300629RF SX7350421RF SX7350425RF SX7350429RF SX7350621RF SX7350625RF SX7350629RF SX7400421RF SX7400425RF SX7400429RF SX7400621RF SX7400625RF SX7400629RF SX7450421RF SX7450425RF SX7450429RF SX7450621RF SX7450625RF SX7450629RF EdgeGlidePath REF: SEGP0221 SEGP0225 SEGP0231 EdgeOne Fire REF: SEOFAST21 SEOFAST25 SEOFAST31 SEOFLG21 SEOFLG25 SEOFLG31 SEOFMED21 SEOFMED25 SEOFMED31 SEOFPRI21 SEOFPRI25 SEOFPRI31 SEOFSM21 SEOFSM25 SEOFSM31 EdgeOne Fire GlidePath REF: SEOFGP21 SEOFGP25 SEOFGP31 EdgeTaper REF: SET21MM SET25MM SET31MM SETF121 SETF125 SETF131 SETF221 SETF225 SETF231 SETF321 SETF325 SETF331 SETF421 SETF425 SETF431 SETF521 SETF525 SETF531 SETS121 SETS125 SETS131 SETS221 SETS225 SETS231 SETSX19 EdgeTaper Platinum REF: SETF121HT SETF125HT SETF131HT SETF221HT SETF225HT SETF231HT SETF321HT SETF325HT SETF331HT SETF421HT SETF425HT SETF431HT SETF521HT SETF525HT SETF531HT SETP21MM SETP25MM SETP31MM SETS121HT SETS125HT SETS131HT SETS221HT SETS225HT SETS231HT SETSX19HT EdgeSequel Sapphire REF: SES150421 SES150425 SES150625 SES150631 SES200421 SES200425 SES200621 SES200625 SES200631 SES250421 SES250425 SES250621 SES250625 SES250821 SES250825 SES250831 SES300421 SES300425 SES300621 SES300625 SES300631 SES350421 SES350425 SES350431 SES350621 SES350625 SES400421 SES400425 SES400625 SES400631 SES450421 SES450425 SES450431 SES450631 SES500421 SES500431 SES500625 SES550421 SES550425 SES600421 SES600425 SES600431 SES700421 SES700425 SES800425 SES900425 SESSAST0421 SESSAST0421L SESSAST0425 SESSAST0425L SESSAST0431 SESSAST0431L SESSAST0621 SESSAST0625 SESSAST0631 SESSAST0631L Endodontic files are intended to be used to clean, shape, and debride the root canal system.
FDA recall Z-1114-2025 — US Endodontics, LLC is recalling 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 SX7300425RF SX7300429RF SX7300621RF SX7300625RF SX7300629RF SX7350421RF SX7350425RF SX7350429RF SX7350621RF SX7350625RF SX7350629RF SX7400421RF SX7400425RF SX7400429RF SX7400621RF SX7400625RF SX7400629RF SX7450421RF SX7450425RF SX7450429RF SX7450621RF SX7450625RF SX7450629RF EdgeGlidePath REF: SEGP0221 SEGP0225 SEGP0231 EdgeOne Fire REF: SEOFAST21 SEOFAST25 SEOFAST31 SEOFLG21 SEOFLG25 SEOFLG31 SEOFMED21 SEOFMED25 SEOFMED31 SEOFPRI21 SEOFPRI25 SEOFPRI31 SEOFSM21 SEOFSM25 SEOFSM31 EdgeOne Fire GlidePath REF: SEOFGP21 SEOFGP25 SEOFGP31 EdgeTaper REF: SET21MM SET25MM SET31MM SETF121 SETF125 SETF131 SETF221 SETF225 SETF231 SETF321 SETF325 SETF331 SETF421 SETF425 SETF431 SETF521 SETF525 SETF531 SETS121 SETS125 SETS131 SETS221 SETS225 SETS231 SETSX19 EdgeTaper Platinum REF: SETF121HT SETF125HT SETF131HT SETF221HT SETF225HT SETF231HT SETF321HT SETF325HT SETF331HT SETF421HT SETF425HT SETF431HT SETF521HT SETF525HT SETF531HT SETP21MM SETP25MM SETP31MM SETS121HT SETS125HT SETS131HT SETS221HT SETS225HT SETS231HT SETSX19HT EdgeSequel Sapphire REF: SES150421 SES150425 SES150625 SES150631 SES200421 SES200425 SES200621 SES200625 SES200631 SES250421 SES250425 SES250621 SES250625 SES250821 SES250825 SES250831 SES300421 SES300425 SES300621 SES300625 SES300631 SES350421 SES350425 SES350431 SES350621 SES350625 SES400421 SES400425 SES400625 SES400631 SES450421 SES450425 SES450431 SES450631 SES500421 SES500431 SES500625 SES550421 SES550425 SES600421 SES600425 SES600431 SES700421 SES700425 SES800425 SES900425 SESSAST0421 SESSAST0421L SESSAST0425 SESSAST0425L SESSAST0431 SESSAST0431L SESSAST0621 SESSAST0625 SESSAST0631 SESSAST0631L Endodontic files are intended to be used to clean, shape, and debride the root canal system. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-1114-2025: US Endodontics, LLC is recalling 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 SX7300425RF SX7300429RF SX7300621RF SX7300625RF SX7300629RF SX7350421RF SX7350425RF SX7350429RF SX7350621RF SX7350625RF SX7350629RF SX7400421RF SX7400425RF SX7400429RF SX7400621RF SX7400625RF SX7400629RF SX7450421RF SX7450425RF SX7450429RF SX7450621RF SX7450625RF SX7450629RF EdgeGlidePath REF: SEGP0221 SEGP0225 SEGP0231 EdgeOne Fire REF: SEOFAST21 SEOFAST25 SEOFAST31 SEOFLG21 SEOFLG25 SEOFLG31 SEOFMED21 SEOFMED25 SEOFMED31 SEOFPRI21 SEOFPRI25 SEOFPRI31 SEOFSM21 SEOFSM25 SEOFSM31 EdgeOne Fire GlidePath REF: SEOFGP21 SEOFGP25 SEOFGP31 EdgeTaper REF: SET21MM SET25MM SET31MM SETF121 SETF125 SETF131 SETF221 SETF225 SETF231 SETF321 SETF325 SETF331 SETF421 SETF425 SETF431 SETF521 SETF525 SETF531 SETS121 SETS125 SETS131 SETS221 SETS225 SETS231 SETSX19 EdgeTaper Platinum REF: SETF121HT SETF125HT SETF131HT SETF221HT SETF225HT SETF231HT SETF321HT SETF325HT SETF331HT SETF421HT SETF425HT SETF431HT SETF521HT SETF525HT SETF531HT SETP21MM SETP25MM SETP31MM SETS121HT SETS125HT SETS131HT SETS221HT SETS225HT SETS231HT SETSX19HT EdgeSequel Sapphire REF: SES150421 SES150425 SES150625 SES150631 SES200421 SES200425 SES200621 SES200625 SES200631 SES250421 SES250425 SES250621 SES250625 SES250821 SES250825 SES250831 SES300421 SES300425 SES300621 SES300625 SES300631 SES350421 SES350425 SES350431 SES350621 SES350625 SES400421 SES400425 SES400625 SES400631 SES450421 SES450425 SES450431 SES450631 SES500421 SES500431 SES500625 SES550421 SES550425 SES600421 SES600425 SES600431 SES700421 SES700425 SES800425 SES900425 SESSAST0421 SESSAST0421L SESSAST0425 SESSAST0425L SESSAST0431 SESSAST0431L SESSAST0621 SESSAST0625 SESSAST0631 SESSAST0631L Endodontic files are intended to be used to clean, shape, and debride the root canal system.
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-1114-2025 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
Due to devices being irradiated above the established specification which my result in package integrity issues.
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.