ProUltra PUSURG3Recalls & reported problems
Tulsa Dental Products LLC · ProUltra Surgical #3 pack · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D716PUSURG31), received between Sep 14, 2024 and Feb 19, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗MalfunctionSep 14, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROULTRA SURGICAL #3 PACK TIP BROKE DURING USE. ALL FRAGMENTS WERE RETRIEVED, NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20219685 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.