Prolystica 1C3208Recalls & reported problems
Steris Corporation · Prolystica 2X Concentrate Neutral 1-Gallon is designed for use in both manual and automated cleaning of appropriate medical devices including surgical instruments. · 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 00724995090968), received between Jul 29, 2026 and Jul 29, 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
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Insufficient Device Problem Information
The user facility reported that an employee was exposed to Prolystica 2X Concentrate Neutral Detergent for approximately two years, and, per the employee, their physician believes they have become "sensitized" to the product. The employee sought medical treatment and is currently under the care of an orthopedic surgeon.
Patient problems: Chemical Exposure
MAUDE report 50075173 ↗
Other Cleaner, ultrasonic, medical instrument devices
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- Triton 72Ultra Clean Systems, Inc. · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
- Triton 36Ultra Clean Systems, Inc. · 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
- Prolystica 1C2308Steris Corporation · Cleaner, ultrasonic, medical instrument2 reports
- 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.