SYSTEM 1 endoRecalls & reported problems
Corporation Steris Canada · SYSTEM 1 endo Liquid Chemical Sterilant Processing System with Touchscreen is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices. · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00724995170554), received between Dec 21, 2022 and May 29, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
- Leak/Splash2
- Failure to Align1
- Improper or Incorrect Procedure or Method1
- Mechanical Problem1
Patient problems
- Burn(s)2
- No Clinical Signs, Symptoms or Conditions2
- Upper Respiratory Tract Irritation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT DURING A CYCLE FOR THEIR SYSTEM 1 ENDO, WATER WITH STERILANT LEAKED OUT ONTO THE FLOOR. USER FACILITY PERSONNEL PRESENT IN THE AREA EXPERIENCED "RESPIRATORY ISSUES" AND WENT TO THE EMERGENCY DEPARTMENT. IT IS UNKNOWN IF TREATMENT WAS ADMINISTERED.
Patient problems: Upper Respiratory Tract Irritation
MAUDE report 22103969 ↗MalfunctionMar 27, 2025Failure to Align; Insufficient Device Problem Information; Failure to Align; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THEIR SYSTEM 1 ENDO LIQUID CHEMICAL STERILANT PROCESSING SYSTEM WAS LEAKING WATER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21709181 ↗MalfunctionDec 12, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THEIR SYSTEM 1 ENDO LIQUID CHEMICAL STERILANT PROCESSING SYSTEM WOULD NOT DRAIN PROPERLY AND HAD TROUBLE OPENING THE DOOR. PATIENT PROCEDURES WERE SUBSEQUENTLY POSTPONED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919283 ↗MalfunctionFeb 8, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT DURING A PROCESSING CYCLE FOR THEIR SYSTEM 1 ENDO SYSTEM, THE LID "POPPED" OPENED SUBSEQUENTLY CAUSING LIQUID TO LEAK OUT OF THE UNIT AND ONTO THE FLOOR. USER FACILITY PERSONNEL PROCEEDED TO CLEAN UP THE LIQUID AND IN THE PROCESS EXPERIENCED INHALATION/IRRITATION. ONE OF THE EMPLOYEES OBTAINED A BURN ON HER FOREARM AND SOUGHT AND RECEIVED MEDICAL TREATMENT.
Patient problems: Burn(s)
MAUDE report 16330456 ↗MalfunctionDec 21, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN WHILE HANDLING A CUP OF S40 STERILANT CONCENTRATE. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.
Patient problems: Burn(s)
MAUDE report 16028938 ↗
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- McKesson 68-101400Mckesson Medical-Surgical Inc. · Sterilant, Medical Devices1 recall0 reports
- CIDEX™ 20390Advanced Sterilization Products Services Inc. · Sterilant, medical devices33 reports
- Rapicide High Level Disinfectant and Sterilant ML02-0059Medivators Inc. · Sterilant, Medical Devices6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.