ProUltra PUENDO5Recalls & reported problems
Tulsa Dental Products LLC · ProUltra Endo Tip #5 pack · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI D716PUENDO51), received between Sep 15, 2023 and Apr 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #5 PACK BROKE DURING FIRST 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 21911307 ↗MalfunctionSep 5, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROULTRA ENDO TIP #5 PACK BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146980 ↗MalfunctionSep 21, 2023Break; Break
IN THIS EVENT IT IS REPORTED A PROULTRA ENDO TIP #5 PACK BROKE DURING USE. THE TIP WAS RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17789966 ↗MalfunctionSep 15, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA ENDO TIP #5 PACK BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17754703 ↗
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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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