Amsco Evolution HC-2000Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The Amsco Evolution Floorloader - Large. This Amsco Evolution SFPP Steam Sterilizer is configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units are equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, Dart (Bowie-Dick) and vacuum leak 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 00724995151553), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Limb Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Use of Device Problem
THE USER FACILITY REPORTED THAT WHILE HANDLING THE CART INSIDE OF THEIR MEDIUM EVOLUTION STERILIZER, THE DOOR CLOSED AND CONTACTED THE EMPLOYEE'S HAND. MEDICAL TREATMENT WAS SOUGHT; HOWEVER, IT IS UNKNOWN WHAT MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Limb Pain
MAUDE report 25302569 ↗
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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.