WaveOne Gold Rotary FileRecalls & reported problems across all models
Tulsa Dental Products LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 109
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of WaveOne Gold Rotary File by Tulsa Dental Products LLC in the FDA's device registry (GUDID). Together they are named in 109 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2023 and Mar 31, 2026 — classified as 3 injuries, 106 malfunctions.
The most frequently reported specific device problem is “Break” (109 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 WaveOne Gold Rotary File problems
Device problems
- Break109
Patient problems
- Device Embedded In Tissue or Plaque89
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Tooth Loss2
WaveOne Gold Rotary File models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WaveOne Gold Rotary File WGPRIME25FILE, PULP CANAL, ENDODONTIC68 reports
- WaveOne Gold Rotary File WGSMALL25FILE, PULP CANAL, ENDODONTIC15 reports
- WaveOne Gold Rotary File WGPRIME21FILE, PULP CANAL, ENDODONTIC11 reports
- WaveOne Gold Rotary File WGPRIME25DEMOFILE, PULP CANAL, ENDODONTIC4 reports
- WaveOne Gold Rotary File WGMEDIUM25FILE, PULP CANAL, ENDODONTIC3 reports
- WaveOne Gold Rotary File WGSMALL31FILE, PULP CANAL, ENDODONTIC3 reports
- WaveOne Gold Rotary File WGPRIME31FILE, PULP CANAL, ENDODONTIC2 reports
- WaveOne Gold Rotary File WGSMALL21FILE, PULP CANAL, ENDODONTIC2 reports
- WaveOne Gold Rotary File WGLARGE21FILE, PULP CANAL, ENDODONTIC1 report
Recent WaveOne 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.
MalfunctionMar 31, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24744658 ↗MalfunctionMar 30, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24714090 ↗MalfunctionMar 30, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25 MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24714020 ↗MalfunctionMar 30, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24713705 ↗MalfunctionMar 30, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24713657 ↗MalfunctionMar 2, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24485194 ↗MalfunctionJan 28, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE SMALL 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE TOOTH. PATIENT WAS INFORMED AND THE FILE WAS DISCARDED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24199285 ↗MalfunctionJan 28, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS LEFT IN THE TOOTH. PATIENT WAS INFORMED. FILE WAS DISCARDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24198923 ↗MalfunctionJan 8, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 3-FILE STER 31MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24002727 ↗MalfunctionDec 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE TOOTH, THE PATIENT WILL BE MONITORED AND FOLLOWED UP WITH AFTER ROOT CANAL TREATMENT. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23906779 ↗MalfunctionDec 23, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM DEMO FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23878436 ↗MalfunctionDec 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND REMAINS IN THE CANAL. FURTHER TREATMENT IS PLANNED. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23852946 ↗MalfunctionDec 16, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6 FILE STER 21MM FILE 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 23818570 ↗MalfunctionOct 24, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380950 ↗InjuryOct 24, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. PATIENT REFERRED TO SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23380906 ↗
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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