ProUltra PUSURG1Recalls & reported problems
Tulsa Dental Products LLC · ProUltra Surgical #1 pack · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D716PUSURG11), received between Jun 4, 2026 and Jun 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.