WaveOne Gold GliderRecalls & reported problems across all models
Tulsa Dental Products LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of WaveOne Gold Glider by Tulsa Dental Products LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2023 and May 27, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Break” (23 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 Glider problems
Device problems
- Break23
Patient problems
- Device Embedded In Tissue or Plaque20
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
WaveOne Gold Glider models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WaveOne Gold Glider TSTW1GG325015FILE, PULP CANAL, ENDODONTIC17 reports
- WaveOne Gold Glider TSTW1GG321015FILE, PULP CANAL, ENDODONTIC6 reports
Recent WaveOne Gold Glider 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 WAVEONE GOLD GLIDER 015-02/25 MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND THE PATIENT WAS REFERRED TO AN ENDODONTIST FOR FURTHER TREATMENT. REPORTEDLY, NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25299367 ↗MalfunctionMay 27, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/21MM BLISTER 3 US FILE BROKE DURING USE. ALL BROKEN PARTS HAVE BEEN RETRIEVED FROM PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298715 ↗MalfunctionApr 20, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE PATIENT'S TOOTH. PATIENT WILL BE KEPT UNDER OBSERVATION; TREATMENT OPTIONS WILL BE DISCUSSED WITH THE PATIENT THAT MAY INCLUDE RETREATMENT OR REMOVAL OF THE TOOTH. REPORTEDLY, NO INJURY. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24923697 ↗MalfunctionAug 18, 2025Break; Break
IN THE EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22828798 ↗MalfunctionAug 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART HAS NOT BEEN RETRIEVED FROM PATIENT'S MOUTH. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22795062 ↗MalfunctionAug 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART HAS BEEN RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22794871 ↗MalfunctionJul 23, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25 MM BLISTER 6 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IT UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 22574465 ↗MalfunctionMay 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART WAS LEFT IN THE TOOTH AND WAS INCORPORATED INTO THE FILLING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22063720 ↗MalfunctionMay 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. DOCTOR WAS WORKING ON A CALCIFIED CANAL ON TOOTH #5, APPROXIMATELY 3MM OF THE TIP BROKE NEAR THE APEX. DOCTOR FILLED BEHIND. FILE WAS DISCARDED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22025229 ↗MalfunctionMay 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. CASE 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22025066 ↗MalfunctionMar 24, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 21MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED, FILE REMAINS IN CANAL. REPORTEDLY, NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21678547 ↗MalfunctionMar 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/21MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21643350 ↗MalfunctionNov 12, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT 2 WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILES BROKE DURING USE. THE BROKEN PARTS COULD NOT BE RETRIEVED. FURTHER TREATMENT IS EXPECTED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20664876 ↗MalfunctionSep 12, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200517 ↗MalfunctionJun 26, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. THE CANAL WAS TREATED AND THE PATIENT WILL RETURN FOR FURTHER TREATMENT. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19613379 ↗
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 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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