Amsco Evolution HC-900Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevacuum 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00724995151621), received between Sep 19, 2022 and May 21, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Fell” (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
- Device Fell2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Device Fell
THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS UNLOADING INSTRUMENTS FROM THEIR TRANSFER CARRIAGE IT FELL TO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244232 ↗MalfunctionJul 18, 2024Device Fell; Device Fell
THE USER FACILITY REPORTED THE TOP PANEL OF THEIR EVOLUTION STERILIZER FELL OFF THE UNIT ONTO AN EMPLOYEE. MEDICAL TREATMENT WAS SOUGHT, THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19775347 ↗MalfunctionSep 19, 2022Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR FOOT WHILE RUNNING A DART CYCLE WITH THEIR EVOLUTION STERILIZER. MEDICAL TREATMENT WAS SOUGHT BUT NOT ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 15446188 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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