Prolystica 1C2408Recalls & reported problems
Steris Corporation · Prolystica HP Enzymatic Manual Cleaner Fragrance Free is formulated to deliver superior performance during manual cleaning process and provides enhanced visibility of instruments by reducing cloudiness in the cleaning solution. · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995211561), received between Oct 6, 2023 and Jan 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Adverse Event Without Identified Device or Use Problem2
- Leak/Splash1
- Use of Device Problem1
Patient problems
- Headache2
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED "NOSE, CHEEK AND EYE SWELLING AND BLISTERING" WHILE HANDLING PROLYSTICA HP ENZYMATIC MANUAL CLEANER. THE EMPLOYEE RECEIVED AN ANTIBIOTIC AND TOPICAL OINTMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 21072215 ↗MalfunctionSep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT TWO EMPLOYEES WERE EXPERIENCING A HEADACHE WHEN USING PROLYSTICA HP ENZYMATIC MANUAL CLEANER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Headache
MAUDE report 20158008 ↗MalfunctionOct 6, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT 5 EMPLOYEES EXPERIENCED HEADACHES WHEN USING PROLYSTICA HP ENZYMATIC MANUAL CLEANER. THE EMPLOYEES SELF-TREATED WITH ADVIL AND TYLENOL.
Patient problems: Headache
MAUDE report 17885376 ↗
Other Cleaner, ultrasonic, medical instrument devices
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- Prolystica 1C3308Steris Corporation · Cleaner, ultrasonic, medical instrument8 reports
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- Prolystica 1C2308Steris Corporation · Cleaner, ultrasonic, medical instrument2 reports
- InnoWave IWULTRAMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument1 report
- InnoWave IWULTRAPLMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.