PWR Handpiece UPHPLEDRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · PWR Piezo LED Handpiece · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889950142728), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Electrical Shock” (1 report).
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
- Unintended Electrical Shock1
Patient problems
- Electric Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Unintended Electrical Shock
WHILE USING THE DEVICE, THE HANDPIECE SERVICE LIGHT ON THE UNIT LIT UP, AND THE HANDPIECE BECAME EXTREMELY HOT, CAUSING AN ELECTRIC SHOCK TO THE DOCTOR'S HAND THAT WAS HOLDING IT.
Patient problems: Electric Shock
MAUDE report 24402335 ↗
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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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