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Amsco Evolution HC-1500 (REF UE03)Recalls & reported problems

Steris Mexico, S. de R.L. de C.V. · The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units can be equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, and daily air removal test cycles. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995151539), received between Oct 29, 2022 and Oct 29, 2022 — classified as 1 malfunction.

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.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 29, 2022Leak/Splash; Leak/Splash

    THE USER FACILITY REPORTED THAT THE DRAIN ON THEIR EVOLUTION STERILIZER WAS EMITTING STEAM. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15695855 ↗

Other Sterilizer, steam devices

All Sterilizer, steam devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.