ProTaper Ultimate Rotary File PULRSL25Recalls & reported problems
Tulsa Dental Products LLC · ProTaper Ultimate Endodontic File Slider glide path file · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D716PULRSL251), received between Nov 6, 2023 and Feb 12, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
Patient problems
- Device Embedded In Tissue or Plaque6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PRO-TAPER ULTIMATE SLIDER 25MM X6 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED FROM THE TOOTH. ADDITIONAL TREATMENT WILL BE NEEDED, INCLUDING SURGERY. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24324719 ↗MalfunctionFeb 18, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ULTIMATE ROTARY FILE SLIDER 25MM FILE SEPARATED DURING USE. THE BROKEN FILE COULD NOT BE RETRIEVED AND PATIENT WAS REFERRED TO ENDO FOR EVALUATION OF RETRIEVING FILE AND FINISHING TREATMENT. FILE DISCARDED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21396250 ↗MalfunctionFeb 18, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ULTIMATE ROTARY FILE SLIDER 25MM FILE SEPARATED DURING USE. THE FILE COULD NOT BE RETRIEVED AND THE PATIENT WAS REFERRED FOR FURTHER TREATMENT OF EXTRACTION AND IMPLANT. FILE WAS DISCARDED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21396048 ↗MalfunctionOct 16, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SLIDER 25MM BROKE DURING USE. REPORTEDLY, THE FILE WAS PARTIALLY REMOVED AND PROCEDURE COMPLETED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20462844 ↗MalfunctionMar 7, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE SLIDER 31MM X3 FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL, DOCTOR INCORPORATED INTO FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18855747 ↗MalfunctionNov 6, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SLIDER 25MM BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18072526 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- EdgeTaper SETF225US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall1 report
- Brasseler USA 5026670U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026667U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7300625RFUS 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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