Amsco Evolution HC-1500 (REF UE06)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995151522), received between Feb 17, 2022 and Feb 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.

• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE UPPER PANEL OF THEIR AMSCO EVOLUTION STERILIZER DETACHED AND CONTACTED THE EMPLOYEE. THE USER FACILITY DID NOT DISCLOSE FURTHER DETAILS REGARDING THE INJURY OR IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 24446872 ↗
• MalfunctionJul 29, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT FOLLOWING A DART TEST CYCLE AN EMPLOYEE OPENED THE DOOR TO THEIR AMSCO EVOLUTION STERILIZER AND OBTAINED A BURN. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 22643188 ↗
• MalfunctionFeb 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHILE OPENING THE DOOR ON THEIR MEDIUM EVOLUTION STERILIZER, THE TOP PANEL ON THE STERILIZER FELL AND CONTACTED THE EMPLOYEE. THE EMPLOYEE RECEIVED MEDICAL TREATMENT, BUT IT WAS NOT DISCLOSED WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Bruise/Contusion

  MAUDE report 21441120 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE TOP PANEL ON THEIR 60" EVOLUTION STERILIZER FELL OFF THE UNIT CONTACTING AN EMPLOYEE'S HEAD. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED. THE USER FACILITY DID NOT DISCLOSE WHAT MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 18125399 ↗
• MalfunctionDec 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE TOP PANEL OF THEIR 66" EVOLUTION STERILIZER FELL OFF AND CONTACTED AN EMPLOYEE'S HEAD. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.

  Patient problems: Pain

  MAUDE report 16028605 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE TOP PANEL ON THEIR EVOLUTION STERILIZER FELL OFF OF THE UNIT CONTACTING AN EMPLOYEE'S HEAD. MEDICAL TREATMENT WAS ADMINISTERED (SKIN ADHESIVE).

  Patient problems: Abrasion

  MAUDE report 13552322 ↗