ProTaper Ultimate Rotary File PULRSH25Recalls & reported problems
Tulsa Dental Products LLC · ProTaper Ultimate Endodontic File Shaping File · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D716PULRSH251), received between Jun 16, 2023 and Feb 21, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
Patient problems
- Device Embedded In Tissue or Plaque10
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21431857 ↗MalfunctionMay 24, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19393673 ↗MalfunctionNov 13, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ULTIMATE SHAPER 25MM X6 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND REMAINS IN THE ROOT CANAL. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 18118273 ↗MalfunctionOct 5, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE SHAPER 25MM X6 BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17877488 ↗MalfunctionJun 29, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17229298 ↗MalfunctionJun 29, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17228645 ↗MalfunctionJun 29, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17228308 ↗MalfunctionJun 16, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17146272 ↗MalfunctionJun 16, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17145861 ↗MalfunctionJun 16, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER ULTIMATE ROTARY FILE SHAPER 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17145816 ↗
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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