Prolystica 1C2310Recalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995224943), received between Sep 18, 2026 and Sep 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Insufficient Device Problem Information
The user facility reported that employees experienced hives after handling Prolystica Enzymatic Manual Cleaner. It is unknown if medical treatment was sought or administered.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50818129 ↗
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- InnoWave UnityMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument2 reports
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- InnoWave IWULTRAMedisafe 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.