ProTaper Universal Hand Files PTUHF125Recalls & reported problems
Tulsa Dental Products LLC · ProTaper U Hand F1 25mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 D716PTUHF1251), received between Nov 6, 2024 and Feb 6, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER FIN.25MM/F1 *NOT CE* FILE BROKE DURING USE AND PATIENT FELT PAIN WHEN FILE BROKE. REQUESTED FURTHER INFORMATION AND PRODUCT RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21321358 ↗MalfunctionNov 6, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER FIN.25 MM/F1 *NOT CE* BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20621236 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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