WaveOne Gold Rotary File WGSMALL31Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Reciprocating File Small 31mm · Class 1
All models of WaveOne Gold Rotary File (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D716WGSMALL311), received between Oct 16, 2024 and Jan 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- Device Embedded In Tissue or Plaque2
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionAug 5, 2025Break; Break
IN THIS EVENT IT IS REPORTED A WAVEONE GOLD RECIPROCATING FILE SMALL 31MM FILE BROKE DURING USE. PATIENT WAS REFERRED TO LOCAL ENDO WHO COMPLETED ROOT CANAL TREATMENT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723238 ↗MalfunctionOct 16, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD SMALL 3-FILE STER 31MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND PATIENT WAS REFERRED TO ENDO SPECIALIST.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20462905 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
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- 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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