EdgeTaper SETF225Recalls & reported problems
US Endodontics, LLC · Sterile Endodontic Rotary Files · Class 1
All models of EdgeTaper (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819514029892), 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 this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, 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 FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- Edge File SX7450429RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300625US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS125HTUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500421US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF321US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7250629RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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