ProTaper Gold Rotary FileRecalls & reported problems across all models
Tulsa Dental Products LLC · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 13 models of ProTaper Gold Rotary File by Tulsa Dental Products LLC in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between May 24, 2023 and May 27, 2026 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Break” (61 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. 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
Most reported ProTaper Gold Rotary File problems
Device problems
- Break61
Patient problems
- Device Embedded In Tissue or Plaque34
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information2
ProTaper Gold Rotary File models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ProTaper Gold Rotary File PTGRS125FILE, PULP CANAL, ENDODONTIC13 reports
- ProTaper Gold Rotary File PTGRS221FILE, PULP CANAL, ENDODONTIC10 reports
- ProTaper Gold Rotary File PTGRF121FILE, PULP CANAL, ENDODONTIC7 reports
- ProTaper Gold Rotary File PTGRS121FILE, PULP CANAL, ENDODONTIC6 reports
- ProTaper Gold Rotary File PTGRF225FILE, PULP CANAL, ENDODONTIC5 reports
- ProTaper Gold Rotary File PTGRA25FILE, PULP CANAL, ENDODONTIC4 reports
- ProTaper Gold Rotary File PTGRS225FILE, PULP CANAL, ENDODONTIC4 reports
- ProTaper Gold Rotary File PTGRF325FILE, PULP CANAL, ENDODONTIC3 reports
- ProTaper Gold Rotary File PTGRSX19FILE, PULP CANAL, ENDODONTIC3 reports
- ProTaper Gold Rotary File PTGRF221FILE, PULP CANAL, ENDODONTIC2 reports
- ProTaper Gold Rotary File PTGRF321FILE, PULP CANAL, ENDODONTIC2 reports
- ProTaper Gold Rotary File PTGRA31FILE, PULP CANAL, ENDODONTIC1 report
- ProTaper Gold Rotary File PTGRF125FILE, PULP CANAL, ENDODONTIC1 report
Recent ProTaper Gold Rotary File adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 25MM FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299054 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854041 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F3 25MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854014 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S2 25MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854013 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854012 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854010 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F2 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854009 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S2 25MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854005 ↗MalfunctionApr 13, 2026Break
IN THIS EVEN IT IS REPORTED THAT A PROTAPER GOLD ROTARY F2 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854001 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F3 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853998 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S2 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853992 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT, IT IS REPORTED THAT A PROTAPER GOLD ROTARY S2 25MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853983 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853982 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F3 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853971 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853964 ↗
Other Tulsa Dental Products LLC products
All Tulsa Dental Products 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 13, 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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