Reported Feb 12, 2025 · Ongoing
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK…
US Endodontics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: US Endodontics, LLC · 2809 W Walnut St · Johnson City, TN · 37604-6333
Is this the product you have?
140 of 140 products
| Model / number | Barcodes | Product as published |
|---|---|---|
| — | 00887919811374 | Lot Numbers: 020222033 042624005 060320018 060420001 070820001 071321009 071321010 080523075 111819267 AP120253PK / 00887919811374 |
| — | 00887919811404 | 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 |
| — | 00887919811435 | Lot Number: 110821062 AP125213PK / 00887919811435 |
| — | 00887919811466 | Lot Numbers: 021920313 030222002 030320002 041423016 072320011 101821056 101821057 101821058 111220210 111220211 111220212 111220213 111220214 121119001 AP125253PK / 00887919811466 |
| — | 00887919811497 | 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 |
| — | 00887919811527 | Lot Numbers: 030221289 050324127 061620004 080420319 AP135213PK / 00887919811527 |
| — | 00887919811558 | Lot Numbers: 030221290 080523076 110821061 121521020 AP135253PK / 00887919811558 |
| — | 00887919811589 | Lot Numbers: 040522008 040522009 081723036 081723037 120619106 061120031 072320012 080520055 AP135313PK / 00887919811589 |
| — | 00887919811619 | Lot Number: 032322001 AP145213PK / 00887919811619 |
| — | 00887919811640 | Lot Numbers: 090321002 090920028 111121040 AP145253PK / 00887919811640 |
| — | 00887919811671 | Lot Numbers: 011322052 011322053 040120068 050324126 061620003 072320013 080420318 081123086 111220215 111220217 111220218 111220219 121119002 AP145313PK / 00887919811671 |
| — | 00887919811701 | Lot Numbers: 031620093 040522010 AP1GP213PK / 00887919811701 |
| — | 00887919811732 | Lot Numbers: 090920027 010721055 080321001 101821053 101821054 101821055 AP1GP253PK / 00887919811732 |
| — | 00887919811763 | 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 | |
SX70421MM | 00810047641995 | / 00810047641995 |
| — | 00810047642008 | Lot Numbers: 110421040 120221077 120820037 012121140 012622038 012822018 021021334 030521027 030821036 041221418 042221189 042221250 052421036 052621007 042823044 111021079 SX70425MM / 00810047642008 |
| — | 00810047642015 | 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 |
| — | 00810047642022 | Lot Numbers: 012121138 012822308 021021336 030521029 030821034 032221375 041221420 051721273 111621076 SX70621MM / 00810047642022 |
| — | 00810047642039 | Lot Numbers: 123021037 012121137 012822309 021021337 030521030 041221421 042221248 052421037 111021082 111621077 SX70625MM / 00810047642039 |
- Amount recalled
- Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.))
Where it was sold
- Nationwide
- GA
Why it was recalled
Due to devices being irradiated above the established specification which my result in package integrity issues.
This product could cause temporary or reversible health problems — stop using it.
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