WaveOne Gold Rotary File WGSMALL25Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Reciprocating File Small 25mm · Class 1
All models of WaveOne Gold Rotary File (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI D716WGSMALL251), received between Aug 1, 2023 and Jan 28, 2026 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
- Break15
Patient problems
- Device Embedded In Tissue or Plaque12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
- Tooth Loss1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE SMALL 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND THE PATIENT WAS REFERRED TO A SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21509277 ↗MalfunctionMar 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE SMALL 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND THE PATIENT WAS REFERRED TO A SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21508814 ↗MalfunctionJan 22, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25MM FILE BROKE DURING USE. AN APICOECTOMY WAS PERFORMED TO REMOVE THE BROKEN PART.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21207732 ↗MalfunctionJan 22, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25 MM FILE BROKE DURING USE. AN APICOECTOMY WAS PERFORMED IN ORDER TO REMOVE BROKEN PART.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21207670 ↗MalfunctionJan 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21157110 ↗MalfunctionJan 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21157053 ↗MalfunctionDec 12, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 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 20920992 ↗MalfunctionDec 11, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25MM 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
MAUDE report 20903885 ↗MalfunctionNov 4, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE SMALL 25MM BROKE DURING USE. BROKEN PART COULD NOT BE RETRIEVED AND PATIENT REFERRED TO SPECIALIST.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20597574 ↗MalfunctionNov 4, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE SMALL 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND THE PATIENT REFERRED TO SPECIALIST.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20597573 ↗MalfunctionOct 24, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25MM 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 20522398 ↗MalfunctionJun 25, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE SMALL 25MM BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO PATIENT INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19610194 ↗MalfunctionDec 4, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD SMALL 6-FILE STER 25MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND REMAINS IN THE ROOT CANAL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18255696 ↗InjuryAug 1, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE SMALL 25MM BROKE DURING USE. TOOTH #30 IN WHICH THE FILE BROKE IN WAS EXTRACTED.
Patient problems: Tooth Loss
MAUDE report 17436008 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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