Severity
Moderate
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 SX720062
Reported: February 12, 2025 Initiated: January 2, 2025 #Z-1114-2025 Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)) units
US Endodontics, LLC issued this FDA Devices recall on February 12, 2025. Classified as Moderate severity (Class II). Approximately Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)) units are affected. The recall was issued because: Due to devices being irradiated above the established specification which my result in package integrity issues.. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1114-2025) was formally reported on February 12, 2025, with the manufacturer initiating the action on January 2, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. US Endodontics, LLC is listed as the recalling firm, operating out of Johnson City, TN. Federal records indicate Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Due to devices being irradiated above the established specification which my result in package integrity issues. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.))
Related Recalls
6
6 from same agency
Product Description
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 for Recall
Due to devices being irradiated above the established specification which my result in package integrity issues.
Details
- Recalling Firm
- US Endodontics, LLC
- Units Affected
- 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.
- Location
- Johnson City, TN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1114-2025 |
| Date reported | February 12, 2025 |
| Date initiated | January 2, 2025 |
| Recalling firm | US Endodontics, LLC |
| Units affected | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by US Endodontics, LLC. Units affected: Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)).
Why was this product recalled? ▼
Due to devices being irradiated above the established specification which my result in package integrity issues.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2025. Severity: Moderate. Recall number: Z-1114-2025.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1114-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).