AMSCO 7053HP (REF FH19042)Recalls & reported problems
Corporation Steris Canada · AMSCO 7053HP Washer-Disinfector Steam Heat Unit delivers a validated and cleared process for cleaning reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00724995176662), received between Mar 17, 2022 and May 21, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 19, 2025Open, Classified
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Z-0910-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Leak/Splash5
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
- Mechanical Jam1
- Sparking1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Abrasion2
- Concussion1
- Damage to Ligament(s)1
- Laceration(s)1
- Skin Tears1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT WHILE LOADING INSTRUMENTS FROM AN AMSCO 7053 HP WASHER/DISINFECTOR, THE WASHER DOOR CONTACTED AN EMPLOYEE'S HAND, RESULTING IN SCRATCHES. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Abrasion
MAUDE report 25244251 ↗MalfunctionMar 19, 2026Leak/Splash
THE USER FACILITY REPORTED THAT THEIR AMSCO 7053HP WASHER/DISINFECTOR WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643199 ↗MalfunctionMar 11, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT AN EMPLOYEE SUSTAINED A HAND SPRAIN WHILE REMOVING A RACK FROM THEIR AMSCO 7053 HP WASHER/DISINFECTOR. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND WAS ADVISED TO APPLY ICE. THE EMPLOYEE HAS RETURNED TO WORK.
Patient problems: Damage to Ligament(s)
MAUDE report 24570679 ↗MalfunctionAug 14, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THEIR AMSCO 7053 HP WASHER/DISINFECTOR WAS LEAKING WATER RESULTING IN PROCEDURE DELAYS/CANCELLATIONS. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805975 ↗MalfunctionJul 12, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR AMSCO 7053HP WASHER/DISINFECTOR WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19732838 ↗MalfunctionJan 18, 2024Mechanical Jam; Mechanical Jam
THE USER FACILITY REPORTED THAT AN EMPLOYEE SCRAPED THEIR HAND ON WASHER DOOR AFTER PUSHING A JAMMED RACK INTO A AMSCO 7053HP WASHER. THE USER FACILITY DID NOT DISCLOSE IF ANY MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED TO FACILITY PERSONNEL.
Patient problems: Abrasion
MAUDE report 18536738 ↗MalfunctionSep 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE USER FACILITY REPORTED THAT FOLLOWING A COMPLETED CYCLE, AN EMPLOYEE OBTAINED A CUT TO THEIR FINGER WHILE RETRIEVING AN ITEM FROM THEIR AMSCO 7053HP WASHER/DISINFECTOR. THE EMPLOYEE SELF-TREATED AND CONTINUED WORKING.
Patient problems: Skin Tears
MAUDE report 17746930 ↗MalfunctionJun 22, 2023Leak/Splash; Sparking; Leak/Splash; Sparking
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 7053HP WASHER/DISINFECTOR ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181794 ↗MalfunctionFeb 17, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE SLIPPED AND FELL ON SOAP LEAKING FROM THEIR AMSCO 7053HP WASHER/DISINFECTOR RESULTING IN AN INJURY (CONCUSSION). THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.
Patient problems: Concussion
MAUDE report 16396116 ↗MalfunctionMar 17, 2022Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED AN INJURY TO THEIR HAND WHILE OPERATING THEIR AMSCO 7053HP WASHER/DISINFECTOR. MEDICAL TREATMENT WAS SOUGHT, BUT NOT ADMINISTERED.
Patient problems: Laceration(s)
MAUDE report 13802860 ↗
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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 · each recall links to the FDA recall notice
- 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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