Cleaner, Ultrasonic, Medical Instrument
FDA adverse event reports and recall history for cleaner, ultrasonic, medical instrument (product code FLG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 231
- Deaths
- 2
- Injuries
- 27
- Malfunctions
- 132
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-05-28Open, ClassifiedUnder Investigation by firm
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
- 2024-10-01Open, ClassifiedMaterial/Component Contamination
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
- 2007-11-16TerminatedDevice Design
Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005
Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.
- 2006-08-25TerminatedOther
Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS
Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
- 2006-08-25TerminatedOther
Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS
Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
- TerminatedDevice Design
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.
- TerminatedProcess control
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
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