InnoWave IWULTRARecalls & reported problems
Medisafe Uk Limited · The InnoWave Ultra Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from a variety of reusable surgical instruments. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995152734), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
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.
MalfunctionNov 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED AN "ELECTRICAL SHOCKING SENSATION" AFTER SHE TOUCHED THE INNOWAVE ULTRA PCF SONIC IRRIGATOR. NO REPORT OF INJURY.
Patient problems: Electric Shock
MAUDE report 18161862 ↗
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- Biotrol PC016Young Dental Manufacturing I, LLC · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
- Prolystica 1C3308Steris Corporation · Cleaner, ultrasonic, medical instrument8 reports
- Prolystica 1C2408Steris Corporation · Cleaner, ultrasonic, medical instrument3 reports
- InnoWave UnityMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument2 reports
- Prolystica 1C2308Steris Corporation · Cleaner, ultrasonic, medical instrument2 reports
- InnoWave EcoMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument1 report
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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