WaveOne Gold Rotary File WGPRIME25Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Reciprocating File Primary 25mm · Class 1
All models of WaveOne Gold Rotary File (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This WaveOne Gold rotary file is a 25mm endodontic file used to clean and shape root canals during a root canal procedure. Reports mostly describe the file snapping off during use, with the broken piece sometimes left in the tooth or sealed into the filling. There are 68 reports, no deaths, and one injury, and no recalls name this device. Reports dropped from 33 in the prior 12 months to 8 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI D716WGPRIME251), received between Jun 29, 2023 and Mar 31, 2026 — classified as 1 injury, 67 malfunctions.
The most frequently reported specific device problem is “Break” (68 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break68
Patient problems
- Device Embedded In Tissue or Plaque55
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information9
Recent adverse event reports
The 25 most recent of 68 reports, 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 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 ↗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 ↗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 ↗MalfunctionSep 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 REMAINS AND WAS INCORPORATED INTO THE FILLING. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23096270 ↗MalfunctionSep 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 25MM FILE BROKE DURING USE. THE BROKEN PARTS REMAIN IN PATIENT'S TOOTH. NO INJURY OCCURRED. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23096147 ↗MalfunctionAug 28, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE BROKE DURING USE. THE ROOT CANAL TREATMENT WAS STOPPED DUE TO THE FILE SUDDENLY BREAKING. THE BROKEN PART WAS CAREFULLY REMOVED, ENSURING THAT NO FRAGMENTS REMAINED. FURTHER INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912012 ↗MalfunctionAug 18, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT 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 22828657 ↗MalfunctionAug 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE BROKE DURING USE. REPORTEDLY, BROKEN PART WAS RETRIEVED BUT NO INFORMATION WAS RECEIVED ABOUT ANY PATIENT INJURY. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22704763 ↗MalfunctionJun 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22142159 ↗MalfunctionJun 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25 MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22142117 ↗MalfunctionMay 5, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. PATIENT WAS REFERRED TO ENDO SPECIALIST WHO REMOVED THE FILE AND COMPLETED THE PROCEDURE. FILE DISCARDED. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960264 ↗MalfunctionApr 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVE ONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. FURTHER TREATMENT IS PENDING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21926306 ↗MalfunctionApr 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT 2 WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM BROKE DURING USE. THE BROKEN PARTS REMAIN IN THE CANAL. PATIENT REFERRED TO AN ENDODONTIST. OUTCOME UNKNOWN AS OF THIS MDR.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21771487 ↗MalfunctionApr 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED FROM THE CANAL AND THE PATIENT WAS REFERRED TO AN ENDODONTIST.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21765359 ↗MalfunctionMar 28, 2025Break; Break
IN THIS CASE IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25 MM BROKE DURING USE. DOCTOR DID NOT PROVIDE ANY OTHER DETAILS. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21724355 ↗MalfunctionMar 28, 2025Break; Break
IN THIS CASE IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25 MM BROKE DURING USE. DOCTOR DID NOT PROVIDE ANY OTHER DETAILS. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21724350 ↗MalfunctionMar 28, 2025Break; Break
IN THIS CASE IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25 MM BROKE DURING USE. DOCTOR DID NOT PROVIDE ANY OTHER DETAILS. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21724307 ↗MalfunctionMar 28, 2025Break; Break
IN THIS CASE IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY 25 MM BROKE DURING USE. DOCTOR DID NOT PROVIDE ANY OTHER DETAILS. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21724253 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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