Amsco EvolutionRecalls & reported problems across all models
Steris Mexico, S. de R.L. de C.V. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of Amsco Evolution by Steris Mexico, S. de R.L. de C.V. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2022 and Aug 5, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Amsco Evolution problems
Device problems
- Leak/Splash8
- Detachment of Device or Device Component7
- Device Fell2
- Fire1
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Bruise/Contusion2
- Burn(s)2
- Insufficient Information2
- Pain2
- Abrasion1
- Limb Pain1
Amsco Evolution models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Amsco Evolution HC-1200Sterilizer, steam6 reports
- Amsco Evolution HC-1500Sterilizer, steam6 reports
- Amsco Evolution HC-1200Sterilizer, steam3 reports
- Amsco Evolution HC-900Sterilizer, steam3 reports
- Amsco Evolution HC-1500Sterilizer, steam1 report
- Amsco Evolution HC-2000Sterilizer, steam1 report
Recent Amsco Evolution adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Steris Mexico, S. de R.L. de C.V. products
All Steris Mexico, S. de R.L. de C.V. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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