Prolystica 1C3308Recalls & reported problems
Steris Corporation · Prolystica 2X Concentrate Enzymatic Presoak and Cleaner 1-Gallon is a low foaming cleaner designed for both manual and automated cleaning. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00724995087517), received between Jul 13, 2022 and Mar 20, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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. 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
- Leak/Splash4
- Insufficient Device Problem Information2
- Use of Device Problem2
Patient problems
- Burn(s)1
- Burning Sensation1
- Eye Irritation1
- Eye Pain1
- Headache1
- Rash1
- Skin Burning Sensation1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT EMPLOYEES ARE EXPERIENCING "SKIN IRRITATION" WHILE HANDLING PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Skin Burning Sensation
MAUDE report 24649704 ↗MalfunctionSep 5, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE OBTAINED BURNS ON THEIR KNEES WHILE HANDLING PROLYSTICA CONCENTRATE ENZYMATIC CLEANER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND RECEIVED ANTIBIOTICS.
Patient problems: Burn(s)
MAUDE report 22976490 ↗MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED AN EMPLOYEE EXPERIENCED A "FACIAL REACTION" WHILE HANDLING PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (ALLERGY MEDICATION).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 21943036 ↗MalfunctionJan 16, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT TWO EMPLOYEES OBTAINED A BURN AND A RASH ON THEIR STOMACH AND FOREARMS AFTER CONTACTING PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Rash
MAUDE report 21170626 ↗MalfunctionJan 10, 2025Leak/Splash; Leak/Splash
USER FACILITY PERSONNEL REPORTED VIA A CHEMTREC REPORT THAT WHEN AN EMPLOYEE WAS CLEANING INSTRUMENTS, PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER "SPLASHED" INTO THEIR EYES. THE EMPLOYEE IMMEDIATELY RINSED THEIR EYES WITH WATER AND REPORTED "BURNING AND IRRITATION."
Patient problems: Eye Irritation
MAUDE report 21126895 ↗MalfunctionMay 3, 2024Leak/Splash; Leak/Splash
A USER FACILITY EMPLOYEE REPORTED VIA CHEMTREC REPORT THAT SHE "SPILLED" PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER ONTO HER RIGHT LEG. THE EMPLOYEE STATED SHE EXPERIENCED A "BURNING" SENSATION AND WASHED THE AFFECTED AREA FOR 15 MINUTES. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.
Patient problems: Burning Sensation
MAUDE report 19241583 ↗MalfunctionMar 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN INDIVIDUAL EXPERIENCED A LEFT EYE EXPOSURE TO PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (EYE FLUSH).
Patient problems: Eye Pain
MAUDE report 16504687 ↗MalfunctionJul 13, 2022Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT EMPLOYEES EXPERIENCED INHALATION/IRRITATION AFTER HANDLING THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. NO MEDICAL TREATMENT SOUGHT OR ADMINISTERED.
Patient problems: Headache
MAUDE report 15008621 ↗
Other Cleaner, ultrasonic, medical instrument devices
- Triton 72Ultra Clean Systems, Inc. · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
- Triton 36Ultra Clean Systems, Inc. · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
- Biotrol PC016Young Dental Manufacturing I, LLC · Cleaner, Ultrasonic, Medical Instrument1 recall0 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
- Prolystica 1C2310Steris Corporation · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page