InnoWave UnityRecalls & reported problems
Medisafe Uk Limited · The InnoWave Unity 20 Ultrasonic Irrigator is designed to process up to 16 lumened devices, or up to 35 lbs. per cycle of non-lumened devices · Class 1
- 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 00724995193737), received between Mar 28, 2025 and May 20, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Break
THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THEIR INNOWAVE PCF SONIC IRRIGATOR. NO REPORT OF INJURY.
Patient problems: Insufficient Information
MAUDE report 25228660 ↗MalfunctionMar 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A CUT ON THEIR HAND FROM A "SHARP EDGE" OF THE DOORSTOP WHILE CHANGING CHEMICALS IN AN INNOWAVE UNITY 20 ULTRASONIC IRRIGATOR. THE EMPLOYEE RECEIVED A BANDAGE.
Patient problems: Laceration(s)
MAUDE report 21724191 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.