FDA Medical devices recall ·
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK… recall
- Recall number
- Z-1114-2025
- Date
- (initiated January 2, 2025)
- Company / brand
- US Endodontics, LLC
2809 W Walnut St, Johnson City, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.))
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to devices being irradiated above the established specification which my result in package integrity issues.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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:
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: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1114-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.