Amsco Evolution HC-1200 (REF UE02)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995151515), received between Aug 31, 2022 and Oct 25, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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
- Leak/Splash2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR EVOLUTION STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY. REPORT OF PROCEDURE DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18006779 ↗MalfunctionAug 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED AN INJURY TO THEIR SHOULDER WHILE OPENING THE DOOR TO THEIR 54" EVOLUTION STERILIZER. THE EMPLOYEE WAS SENT TO THE ER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Pain
MAUDE report 17608343 ↗MalfunctionAug 31, 2022Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER AND STEAM WERE LEAKING FROM THEIR EVOLUTION STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327747 ↗
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- NA AX083020003Steris Mexico, S. de R.L. de C.V. · Sterilizer, steam23 reports
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- Atlas AX0660230830000013Steris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 600 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.