ProUltra PUENDO3Recalls & reported problems
Tulsa Dental Products LLC · ProUltra Endo Tip #3 pack · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D716PUENDO31), received between Nov 22, 2024 and Apr 24, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 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 ↗MalfunctionNov 22, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROULTRA ENDO TIP #3 PACK TIP BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759291 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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