Recall archive / FDA device enforcement
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK ... — FDA record Z-1114-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 2, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 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.
- Reason
- Due to devices being irradiated above the established specification which my result in package integrity issues.
- Classification
- Class II
- Recalling firm
- US Endodontics, LLC
- Quantity
- Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.))
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1114-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Device SKU / GTIN code AP120213PK / 00887919811343 Lot Numbers: 020222033 042624005 060320018 060420001 070820001 071321009 071321010 080523075 111819267 AP120253PK / 00887919811374 Lot Numbers: 042821235 042821235 042821236 042821236 042821238 051024026 051423101 051423102 060420003 060420004 063020331 063020332 063020333 080321003 080321004 080523077 080523078 101821059 101821060 101821061 101821062 101821063 120219105 121120218 121120221 121120222 121120223 AP120313PK / 00887919811404 Lot Number: 110821062 AP125213PK / 00887919811435 Lot Numbers: 021920313 030222002 030320002 041423016 072320011 101821056 101821057 101821058 111220210 111220211 111220212 111220213 111220214 121119001 AP125253PK / 00887919811466 Lot Numbers: 010622001 012121085 012121086 012121087 012121088 012121089 012121090 012121091 012121092 021920315 031620090 031620091 031620092 041224032 041224033 051221001 051221600 051423103 051423104 061620001 061620002 062323152 062323153 062921149 062921150 072721067 072721068 080523079 080523080 080523081 090220016 090220018 090220019 101821064 101821066 101821069 121521017 121521018 121521019 AP125313PK / 00887919811497 Lot Numbers: 030221289 050324127 061620004 080420319 AP135213PK / 00887919811527 Lot Numbers: 030221290 080523076 110821061 121521020 AP135253PK / 00887919811558 Lot Numbers: 040522008 040522009 081723036 081723037 120619106 061120031 072320012 080520055 AP135313PK / 00887919811589 Lot Number: 032322001 AP145213PK / 00887919811619 Lot Numbers: 090321002 090920028 111121040 AP145253PK / 00887919811640 Lot Numbers: 011322052 011322053 040120068 050324126 061620003 072320013 080420318 081123086 111220215 111220217 111220218 111220219 121119002 AP145313PK / 00887919811671 Lot Numbers: 031620093 040522010 AP1GP213PK / 00887919811701 Lot Numbers: 090920027 010721055 080321001 101821053 101821054 101821055 AP1GP253PK / 00887919811732 Lot Numbers: 012522001 041224031 051221002 052021052 052021053 052021054 052021055 052021056 060420002 080420317 090220011 090220013 090220015 111819268 AP1GP313PK / 00887919811763 Lot Numbers: 012221001 062022041 O.U.S. product information EdgeFile X7 REF: SX70421MM / 00810047641995 Lot Numbers: 110421040 120221077 120820037 012121140 012622038 012822018 021021334 030521027 030821036 041221418 042221189 042221250 052421036 052621007 042823044 111021079 SX70425MM / 00810047642008 Lot Numbers: 111121037 121421023 121621178 122021018 123021036 123021043 011322185 011322186 011322187 011322204 012121139 012522008 012822012 020222111 021021335 022322010 030521028 030821035 030821228 032221374 041221419 042221190 042221249 050422014 050422015 050422055 050422056 051221005 052021015 012822492 042823045 061823139 062323219 111621075 SX70429MM / 00810047642015 Lot Numbers: 012121138 012822308 021021336 030521029 030821034 032221375 041221420 051721273 111621076 SX70621MM / 00810047642022 Lot Numbers: 123021037 012121137 012822309 021021337 030521030 041221421 042221248 052421037 111021082 111621077 SX70625MM / 00810047642039 Lot Numbers: 121621179 012121136 012822310 021021338 030521031 030521149 030521183 032221376 041221422 042221247 050721024 051221006 052021016 052421038 052421039 080921048 092021061 012822494 050224011 111621078 SX70629MM / 00810047642046 Lot Numbers: 120820043 012121135 030521032 030521148 032221377 041221423 051221007 052021017 052421040 070121048 051721276 012822495 111021084 111621079 SX7170421RF / 00810047641544 Lot Numbers: 120820155 121120287 012121125 012822292 013022001 020222052 032221339 042221037 042221231 050324064 051423001 052421007 120221037 012822496 012822607 062323220 050224012 050524008 111021085 SX7170425RF / 00810047641551 Lot Numbers: 110421037 120820157 121120288 121421019 121621174 122921113 123021026 123021030 123021052 012121124 012622158 012822293 013022002 013022218 020222053 022322002 022622349 030521222 032221340 042221036 050324056 050422004 050422061 051423002 051423006 051423007 052421008 061823011 070323025 070323026 070323027 092021068 071621015 081721021 012822608 071422056 072822033 081122027 082622032 042823046 050623073 061023124 061823140 062323221 050224013 050524009 071422057 SX7170429RF / 00810047641568 Lot Numbers: 120820159 121120289 122921114 012121126 030521023 032221341 052021009 052421009 012822609 111021088 111621083 SX7170621RF / 00810047641575 Lot Numbers: 120820160 121120290 012121127 013022024 022622352 030521022 032221342 042221035 042221232 052421010 012822610 050224014 111021089 111621084 SX7170625RF / 00810047641582 Lot Numbers: 120820161 121120291 012121128 012222117 012222118 012622159 013022025 030521021 030521035 032221343 042221034 042221209 050422030 050721019 052421011 012822611 SX7170629RF / 00810047641599 Lot Numbers: 120820162 121120292 030521020 030521036 032221344 052421012 012822612 111021091 SX7200421RF / 00810047641605 Lot Numbers: 120820163 121120293 012121130 030521019 030521037 032221345 042221033 051024013 052021010 011322046 012822613 072822034 072822035 111021092 111021093 SX7200425RF / 00810047641612 Lot Numbers: 120820164 121120294 121421020 123021027 012121131 012222119 012222120 012822295 021021319 030521018 030521038 032221346 042221032 050324055 050422005 050422006 050422031 050422060 051024014 092021066 071422058 081122028 082622033 050623074 051423017 061023125 061823141 061823142 062323222 050224015 050524010 111621089 111621090 072822036 SX7200429RF / 00810047641629 Lot Numbers: 120820001 121120295 012121600 012622161 022622359 030521017 030521039 032221347 051024015 012822615 062323223 111021098 111621091 SX7200621RF / 00810047641636 Lot Numbers: 120820002 121120296 123021051 012121133 030521016 030521040 032221348 042221031 042221178 050422059 052421013 070323021 012822616 081122029 082622034 062323224 SX7200625RF / 00810047641643 Lot Numbers: 120820003 121120297 121621175 012121134 012222121 012622163 012822296 013022028 022622362 030521015 030521041 032221349 042221030 042221179 050422032 051024016 052021011 052421014 052421015 012822245 012822617 012822499 051522029 071422059 072822037 081122030 082622035 051423018 061023126 062323225 080523038 050224016 111021601 111621600 SX7200629RF / 00810047641650 Lot Numbers: 120820004 120820004 121120298 123021028 012121144 030521014 030521042 032221350 052421016 051522030 111021103 SX7250421RF / 00810047641667 Lot Numbers: 110821050 120221072 120820005 121120299 122921115 123021029 123021050 012121145 012222122 012622164 021021322 030521013 030521043 030821227 032221351 042221029 050422033 050422058 052421017 011322047 012822619 050224017 SX7250425RF / 00810047641674 Lot Numbers: 120221073 120820006 121120300 121321137 121421005 121421012 121421021 121621176 123021049 123021600 012121146 012622165 012622166 022622374 022622376 030521012 030521044 030521600 032221352 042221028 042221181 050422007 050422008 050422009 050422010 052421018 060421001 092021067 081721022 051522031 071422060 071422061 072822038 050623075 051423019 061023127 062323226 050224018 111021106 SX7250429RF / 00810047641681 Lot Numbers: 120820008 121120301 122921116 012121147 030521011 030521045 032221353 012822621 050224019 111021107 SX7250621RF / 00810047641698 Lot Numbers: 120820009 121120302 121120304 122921117 012121148 012822297 030521010 030521046 032221354 042221027 042221182 052421019 120221038 012822501 050623076 061023128 111021108 111021109 SX7250625RF / 00810047641704 Lot Numbers: 111121036 120221074 120820010 121120303 121120305 121621177 122921100 123021048 012121149 012822298 013022031 022622379 022622380 030521009 030521047 032221355 042221026 042221183 050721020 052021012 052421020 052421021 070323020 071621016 012822622 012822502 042823047 050623077 051423020 061823143 050224020 050524011 SX7250629RF / 00810047641711 Lot Numbers: 120820011 121120306 121421022 122921101 012121150 030521008 030521048 032221356 052421022 012822503 111021114 111621104 SX7300421RF / 00810047641728 Lot Numbers: 110821049 120820012 121120307 012121151 021021326 030521007 030521049 032221357 042221025 011322048 041924366 SX7300425RF / 00810047641735 Lot Numbers: 120820013 121120308 122921102 012121152 012822299 013022011 020222058 021021327 022622383 022622384 030521006 030521050 040424042 042221024 042221184 042823006 051423008 052421023 070323019 012822504 042823048 050623078 051423021 062323227 041924367 042024080 050224021 050524012 111021117 SX7300429RF / 00810047641742 Lot Numbers: 120820015 012121153 021021328 030521005 030521051 032221358 041221396 050324054 050422011 012822625 111021118 111621108 SX7300621RF / 00810047641759 Lot Numbers: 120820016 012121154 013022033 030521004 030521052 032221359 041221397 042221023 042221185 050422057 052421024 012822505 111621109 SX7300625RF / 00810047641766 Lot Numbers: 120820017 121621180 012121155 012822300 021021329 030521003 030521053 041221398 042221022 042221186 052021013 052421025 052421026 070323018 042823049 050623079 051423022 061823144 050224022 111021121 SX7300629RF / 00810047641773 Lot Numbers: 120820018 012121156 012822301 030521002 032221360 041221399 052421027 061421122 070121024 042823050 111021123 111621112 SX7350421RF / 00810047641780 Lot Numbers: 120820019 012121157 030521001 030521055 032221361 041221400 042221187 042221254 052421028 012822507 050224023 111021124 111621113 SX7350421RF / 00810047641728 Lot Number: 011322049 SX7350425RF / 00810047641797 Lot Numbers: 120820020 123021031 123021047 012121158 020222060 021021330 030521056 041221401 042221253 050324053 050324065 052421029 120221039 042823051 062323228 050224024 050524013 111021125 111621114 SX7350429RF / 00810047641803 Lot Numbers: 120820021 123021032 030521034 030821052 032221362 041221402 050324052 052421030 012822509 111021127 SX7350621RF / 00810047641810 Lot Numbers: 120820022 012121160 013022036 030821051 030821116 032221363 041221403 052421031 012822510 111621117 SX7350625RF / 00810047641827 Lot Numbers: 120820023 123021046 012121161 012822303 021021331 030821050 030821117 041221404 050324051 050721022 052421032 051721257 012822627 012822511 111621118 SX7350629RF / 00810047641834 Lot Numbers: 120820024 012121162 030821049 030821118 032221364 041221405 111021131 111621120 SX7400421RF / 00810047641841 Lot Numbers: 120820025 012121163 012822028 022622393 030821119 032221365 041221406 042221252 052021014 012822513 SX7400425RF / 00810047641858 Lot Numbers: 120221075 120820026 012121164 012222123 013022017 021021332 030821242 041221407 042221188 042221251 050324050 050422034 052421034 120221040 012822514 042823052 050623080 051423023 050224025 050524014 111021134 SX7400429RF / 00810047641865 Lot Numbers: 110421038 120820027 012121165 022622397 030821046 032221366 041221408 012822628 111021135 SX7400621RF / 00810047641872 Lot Numbers: 120820028 012121166 012822304 013022039 030821045 030821122 032221367 041221409 012822515 111021136 SX7400625RF / 00810047641889 Lot Numbers: 120820029 121421006 123021033 012121167 012822305 021021333 022622399 041221410 050422012 050721023 052421035 051721263 110221059 012822516 012822629 111021137 111621126 SX7400629RF / 00810047641896 Lot Numbers: 110421039 120820030 012121168 012822025 030821043 030821124 032221368 041221411 012822517 111021139 111621127 SX7450421RF / 00810047641902 Lot Numbers: 120820031 012121169 012822024 030821042 030821125 032221369 041221412 012822518 SX7450425RF / 00810047641919 Lot Numbers: 120221076 120820032 123021034 123021045 012121170 012822023 030821041 030821126 041221413 051221004 070323016 080921053 012822519 111621129 SX7450429RF / 00810047641926 Lot Numbers: 120820033 012121171 012822022 030821040 030821127 032221370 041221414 051721267 111021142 SX7450621RF / 00810047641933 Lot Numbers: 120820034 012121143 012822021 013022042 030521024 030821039 032221371 041221415 051721268 111621131 SX7450625RF / 00810047641940 Lot Numbers: 120820035 123021035 123021044 012121142 012822020 012822306 022622404 030521025 030821038 032221372 041221416 050422081 051721269 012822630 111021144 111621132 SX7450629RF / 0081004764... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 12, 2025
- Recall initiation date
- Jan 2, 2025
- Center classification date
- Feb 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.