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Prolystica
STERIS CORPORATION · Model 1C2310 · UDI-DI 00724995224943
FLG
Prescription
10
510(k) clearances
233
Adverse events (2 deaths)
7
Recalls
151
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-31 | Ultra Clean Systems, Inc. | During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. |
| 2024-08-23 | Young Dental Manufacturing I, LLC | The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. |
| 2020-11-19 | Steris Corporation | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the dete |
| 2020-06-26 | Steris Corporation | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. |
| 2007-07-03 | Pacific Bioscience Lab, Inc. | Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns. |
| 2006-06-22 | Steris Corporation | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result i |
| 2006-06-22 | Steris Corporation | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result i |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.