Prolystica 1C2308Recalls & reported problems
Steris Corporation · Prolystica High Performance Enzymatic Manual Cleaner 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
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995154363), received between Nov 16, 2023 and Nov 18, 2024 — classified as 2 malfunctions.
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 Problem2
Patient problems
- Rash2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT TWO EMPLOYEES EXPERIENCED RASHES AFTER CONTACTING PROLYSTICA HP ENZYMATIC MANUAL CLEANER DYE & FRAGRANCE. ONE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT WHILE THE OTHER WENT TO THE ER AND WAS GIVEN PEPCID AND PREDNISONE.
Patient problems: Rash
MAUDE report 20713764 ↗MalfunctionNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A RASH ON THEIR HANDS AND STOMACH AFTER HANDLING PROLYSTICA HP ENZYMATIC MANUAL CLEANER DYE & FRAGRANCE. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.
Patient problems: Rash
MAUDE report 18151576 ↗
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 1C3308Steris Corporation · Cleaner, ultrasonic, medical instrument8 reports
- Prolystica 1C2408Steris Corporation · Cleaner, ultrasonic, medical instrument3 reports
- InnoWave UnityMedisafe Uk Limited · 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