Cleaner, Ultrasonic, Medical Instrument
General Hospital · 21 CFR 880.6150
Recent MDR events
232 adverse event reports on file
- ProlysticaJul 29, 2026InjurySteris Corporation1937531-2026-00006
- ENZYMAX SPRAY GELJun 18, 2026InjuryHu-friedy Manufacturing Co., Llc1416605-2026-00011
- INNOWAVEMay 20, 2026MalfunctionMedisafe Uk Limited9617134-2026-00002
- PROLYSTICAMar 20, 2026MalfunctionSteris Corporation1937531-2026-00002
- PROLYSTICAMar 12, 2026MalfunctionSteris Corporation1937531-2026-00001
- TRITON 36Dec 8, 2025MalfunctionUltra Clean Systems, Inc.23736470
- INNOWAVEDec 5, 2025MalfunctionMedisafe Uk Limited9617134-2025-00015
- PROLYSTICASep 5, 2025MalfunctionSteris Corporation1937531-2025-00007
- PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANERMay 1, 2025MalfunctionSteris Corporation1937531-2025-00006
- PRE-KLENZ POINT OF USE GELApr 11, 2025MalfunctionSteris Corporation1937531-2025-00005
Event type breakdown
Recalls
7 recall events for this product code
- Ultra Clean Systems, Inc.Open, ClassifiedMay 28, 2025
Ultrasonic Cleaning Systems
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
Z-1859-2025 · View FDA record ↗ - Young Dental Manufacturing I, LLCOpen, ClassifiedOct 1, 2024
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.
Z-0008-2025 · View FDA record ↗ - Pacific Bioscience Lab, Inc.TerminatedNov 16, 2007
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 Labo
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.
Z-0182-2008 · View FDA record ↗ - Steris CorporationTerminatedAug 25, 2006
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.
Z-1407-06 · View FDA record ↗ - Steris CorporationTerminatedAug 25, 2006
Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAE
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.
Z-1408-06 · View FDA record ↗ - Steris CorporationTerminatedUnknown
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between
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.
Z-0830-2021 · View FDA record ↗ - Steris CorporationTerminatedUnknown
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intende
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Z-2700-2020 · View FDA record ↗
Registered firms
155 firms currently registered for this product code
Baumer S.a.
MOGI MIRIM - SP Sao Paulo, BR
Dsi Dental Solutions Ltd
Ashdod Southern, IL
Ortho Dental Lab, Llc
Antioch, TN, US
Dent4you Ag
Heerbrugg Sankt Gallen, CH
Germiphene Corp.
BRANTFORD Ontario, CA
Ningbo Just Soon Industrial Limited
Ningbo Zhejiang, CN
Cetylite Industries, Inc.
PENNSAUKEN, NJ, US
Zhengzhou Huaer Electro-optics Technology Co., Ltd.
Zhengzhou Henan, CN
Scican Ltd.
TORONTO Ontario, CA
Chemclean Corporation
Jamaica, NY, US
Getinge Ic Production Poland Sp. Z O.o.
Plewiska Wielkopolskie, PL
Symmetry Surgical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Vintage Chemical Inc.
Fort Wayne, IN, US
Isonic Inc.
Chicago, IL, US
L&r Mfg. Co., Inc
Kearny, NJ, US
Alconox, Llc
White Plains, NY, US
Hdi Inc.
Seongnam-si Gyeonggi, KR
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Ackermann Instrumente Gmbh
RIETHEIM, WEILHEIM Baden-Wurttemberg, DE
Steelco S.p.a.
Riese Pio X Treviso, IT
Sonic Systems, Inc.
Ivyland, PA, US
Shenzhen Jie Bishi Technology Co., Ltd
Shenzhen Guangdong, CN
Iconbeauty (shenzhen) Holding Ltd.
Shenzhen Guangdong, CN
Ultrawave Limited
Cardiff, GB
Oketz Logistics Llc
Coral Gables, FL, US
510(k) clearances
19 clearances for this product code
- Calgon Corp.Dec 20, 1994
K944950 · KLENZYME
- Calgon Vestal Div.Oct 19, 1994
K944494 · ALSA-KLENZ
- Calgon Vestal Div.Oct 7, 1994
K944033 · BILL EVANS-KLENZ
- Calgon Vestal Div.May 18, 1994
K941163 · MON-KLENZ
- Calgon Corp.May 18, 1994
K940263 · NPH-KLENZ
- Calgon Corp.May 9, 1994
K935063 · INSTRU KLENZ
- Medical Polymers, Inc.Apr 15, 1994
K934666 · PDS ULTRACLEAN
- Surgicot, Inc.Apr 13, 1994
K931270 · SURGICLEAN ENZYMATIC INSTRUMENT CLEANER