ProUltra PUSURG2Recalls & reported problems
Tulsa Dental Products LLC · ProUltra Surgical #2 pack · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D716PUSURG21), received between Aug 9, 2023 and Feb 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT PROULTRA SURGICAL #2 PACK BROKE DURING USE. NO INJURY OCCURRED, ABLE TO RETRIEVE BROKEN PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21401417 ↗MalfunctionApr 17, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROULTRA SURGICAL #2 PACK TIP BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19123841 ↗MalfunctionAug 9, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROULTRA SURGICAL #2 PACK TIP BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17486736 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.