Amsco Evolution HC-1200 (REF UE05)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995151508), received between Feb 3, 2022 and Aug 5, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146981 ↗
• MalfunctionJul 9, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR AMSCO EVOLUTION STERILIZER WAS LEAKING WATER AND STEAM ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458129 ↗
• MalfunctionJun 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE TOP PANEL OF THEIR 54" EVOLUTION STERILIZER FELL OFF AND CONTACTED AN EMPLOYEE'S HEAD. NO MEDICAL TREATMENT WAS NOT SOUGHT OR ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221613 ↗
• MalfunctionApr 19, 2023Fire; Fire

  A STERIS SERVICE TECHNICIAN WAS PERFORMING A SERVICE ACTIVITY ON THE USER FACILITY'S EVOLUTION STERILIZER WHEN A BURNING ODOR WAS DETECTED AND SMALL FLAME IN THE WIRING OF THE CONTROL BOX WAS OBSERVED. THE TECHNICIAN PUT OUT THE FLAME. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773156 ↗
• MalfunctionFeb 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE TOP PANEL TO THEIR 54" EVOLUTION STERILIZER FELL OFF AFTER AN EMPLOYEE CLOSED THE STERILIZER'S DOOR. AS THE PANEL FELL, THE EMPLOYEE TRIED TO CATCH IT AND IT CONTACTED THEIR NOSE. THE EMPLOYEE ALSO SUSTAINED AN INJURY TO THEIR SHOULDER. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (ICE PACK).

  Patient problems: Bruise/Contusion

  MAUDE report 16375385 ↗
• MalfunctionFeb 3, 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 13440439 ↗