EdgeTaperRecalls & reported problems across all models
US Endodontics, LLC · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EdgeTaper model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 25 models of EdgeTaper by US Endodontics, LLC in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EdgeTaper recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 2, 2025Open, Classified
Due to devices being irradiated above the established specification which my result in package integrity issues.
Z-1114-2025 · Root cause: Under Investigation by firm · names 25 of these models · Recall details · FDA record ↗
Most reported EdgeTaper problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
EdgeTaper models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EdgeTaper SETF225FILE, PULP CANAL, ENDODONTIC1 recall1 report
- EdgeTaper SET21MMFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET31MMFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETSX19FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETS121FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETS125FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETS131FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETS221FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETS225FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETS231FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF121FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF125FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF131FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF221FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF231FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF321FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF325FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF331FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF431FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF521FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF525FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF531FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Recent EdgeTaper adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Break; Break
THE FILE FRACTURED DURING AN ENDODONTIC TREATMENT (FRACTURE OCCURRED IN THE PATIENT'S MOUTH). THE AFFECTED PATIENT WAS NOT INJURED, AND NO MEDICAL CARE WAS REQUIRED. THE INCIDENT OCCURRED 20 MINUTES AFTER THE START OF THE TREATMENT. THE DENTIST STATED THAT THE INCIDENT HAPPENED DURING THE FIRST USE OF THE PRODUCT AND THAT THEY HAVE EXPERIENCE USING THIS PRODUCT, AS WELL AS A SIMILAR PRODUCT FROM RARE EUO. THE PRACTITIONER STATED THAT THEY DID NOT STERILIZE THE PRODUCT BEFORE USE. THE CLEANING PROTOCOL CONSISTED OF DISINFECTION AND LUBRICATION. REGARDING THE SEX OF THE AFFECTED PATIENT, THE DENTIST INDICATED BOTH MALE AND FEMALE. A REQUEST FOR CLARIFICATION HAS BEEN SENT TO DETERMINE IF MULTIPLE PATIENTS WERE INVOLVED. THE BROKEN FRAGMENTS COULD NOT BE REMOVED. THE SETTINGS USED WERE: POWER - 350 RPM, SPEED + 30 - 150, HANDPIECE USED FKG. THE CANNULA WAS BENT BEFORE INJECTION. THE FILES WERE DISCARDED (NO SAMPLE AVAILABLE FOR INVESTIGATION).QUANTITY OF PARTS IMPACTED BY THE DEFECT: 5.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22359738 ↗
Other US Endodontics, LLC products
All US Endodontics, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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