ProUltraRecalls & reported problems across all models
Tulsa Dental Products LLC · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 10 models of ProUltra by Tulsa Dental Products LLC in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2023 and Jun 4, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Break” (25 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 ProUltra problems
Device problems
- Break25
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
ProUltra models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ProUltra PUENDO3Scaler, ultrasonic6 reports
- ProUltra PUSURG3Scaler, ultrasonic5 reports
- ProUltra PUENDO5Scaler, ultrasonic4 reports
- ProUltra PUSURG2Scaler, ultrasonic3 reports
- ProUltra PUSURG1Scaler, ultrasonic2 reports
- ProUltra PUENDO1-5Scaler, ultrasonic1 report
- ProUltra PUENDO2Scaler, ultrasonic1 report
- ProUltra PUENDO4Scaler, ultrasonic1 report
- ProUltra PUENDO6Scaler, ultrasonic1 report
- ProUltra PUSURG5Scaler, ultrasonic1 report
Recent ProUltra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL #1 PACK BROKE DURING USE. ALL BROKEN PARTS RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391118 ↗MalfunctionJun 4, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL #1 PACK BROKE DURING USE. ALL BROKEN PARTS RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25390784 ↗MalfunctionMay 27, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #6 PACK , THE TIP BROKE DURING FIRST USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25299175 ↗MalfunctionApr 24, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #3 PACK BROKE DURING USE. REPORTEDLY, THE TIP BROKE AT THE LOWEST SETTING OUT OF THE PATIENT'S MOUTH. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984050 ↗MalfunctionApr 20, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #1 PACK BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24923780 ↗MalfunctionMar 17, 2026Break
IN THIS EVENT IT IS REPORTED THAT MULTIPLE PROULTRA ENDO TIP #3 BROKE DURING USE. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY. THIS IS REPORT 2 0F 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618389 ↗MalfunctionMar 17, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #3 BROKE DURING USE. ALL BROKEN PARTS RETRIEVED FROM PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618267 ↗MalfunctionFeb 19, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL #5 BROKE DURING USE. ALL THE BROKEN PARTS WERE RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387342 ↗MalfunctionFeb 19, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL #3 BROKE DURING USE. ALL THE BROKEN PIECES WERE RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387195 ↗MalfunctionFeb 18, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL #3 BROKE DURING USE. ALL BROKEN PIECES WERE RETRIEVED. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380557 ↗MalfunctionFeb 12, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #3 PACK BROKE DURING USE. THE BROKEN PARTS WERE RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321365 ↗MalfunctionJan 19, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL TIP #3 BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108622 ↗MalfunctionJan 6, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #2 BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973428 ↗MalfunctionJan 6, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #3 BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973317 ↗MalfunctionMay 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT PROULTRA SURGICAL #3 PACK - 2 PROULTRA SURGICAL #3 TIPS BROKE DURING USE ON THE SAME PATIENT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024945 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page