PWR Pair APPAIRRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · PWR Pair Combo Unit · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889950142551), received between Jul 8, 2025 and Mar 12, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
Patient problems
- Air Embolism2
- Swelling/ Edema2
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Insufficient Device Problem Information
DENTIST REPORTED WHILE USING THE PWR AIR POLISHER IT WAS DAMAGING THE TISSUE ON GUMS
Patient problems: Unspecified Tissue Injury
MAUDE report 24584082 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A 80+ YEAR OLD PATIENT GOT AN AIR EMBOLISM DURING USE OF THE PWR PAIR.
Patient problems: Air Embolism; Swelling/ Edema
MAUDE report 23355416 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
REPORTED THAT THE PATIENT GOT AIR EMBOLISM DURING AIR POLISHING TREATMENT. PATIENT WAS SENT TO THE HOSPITAL AND STAYED OVERNIGHT.
Patient problems: Air Embolism; Swelling/ Edema
MAUDE report 22436418 ↗
Other AIRBRUSH devices
- AIR-FLOW FT-230HF-0B-302E.M.S. Electro Medical Systems S.A. · Airbrush3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.