AMSCO 7053HP (REF FH19072)Recalls & reported problems
Corporation Steris Canada · The AMSCO 7053HP Washer-Disinfector with Steam Heat 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00724995176655), received between Sep 13, 2023 and Jul 2, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (3 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
- Use of Device Problem3
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
- Leak/Splash1
Patient problems
- Bruise/Contusion3
- No Clinical Signs, Symptoms or Conditions2
- Abrasion1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED AN INJURY WHILE OPERATING A CART TO THEIR AMSCO 7053HP WASHER/DISINFECTOR. THE EMPLOYEE SOUGHT MEDICAL TREATMENT HOWEVER, IT IS UNKNOWN THE TREATMENT THAT MAY HAVE BEEN ADMINISTERED.
Patient problems: Pain
MAUDE report 25695394 ↗MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A SHOULDER BRUISE WHILE ATTEMPTING TO PUSH A RACK INTO TO THEIR AMSCO 7053 HP WASHER/DISINFECTOR. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Bruise/Contusion
MAUDE report 25060160 ↗MalfunctionJan 16, 2026Improper or Incorrect Procedure or Method
THE USER FACILITY REPORTED THAT AFTER AN EMPLOYEE LOADED A CONTAINER ONTO THE RACK IN THEIR AMSCO 7053HP WASHER/DISINFECTOR, THE HANDLE OF THE CONTAINER WAS "STICKING OUT". WHEN THE EMPLOYEE COMMANDED THE WASHER DOOR TO CLOSE, THE HANDLE CONTACTED THE DOOR SUBSEQUENTLY CAUSING THE INTERIOR TEMPERED GLASS TO BREAK. THE GLASS WAS BROKEN IN A SPIDER-LIKE FASHION BUT REMAINED INTACT. A USER FACILITY EMPLOYEE RECEIVED A SMALL CUT ON HER HAND WHEN SHE CONTACTED THE DOOR. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.
Patient problems: Abrasion
MAUDE report 24094388 ↗MalfunctionSep 4, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 7053 HP WASHER/DISINFECTOR ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965137 ↗MalfunctionOct 3, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT "BLACK FLAKES" WERE OBSERVED IN THE CHAMBER OF THEIR AMSCO 7053HP WASHER/DISINFECTOR. USER FACILITY PERSONNEL FOLLOWED THEIR POST-INSPECTION PROCEDURES ACCORDING TO THEIR GOOD HOSPITAL PRACTICES AND INSPECTED ALL INSTRUMENTS PRESENT IN THE CHAMBER. PROCEDURE DELAYS WERE REPORTED AS THE INSTRUMENTS HAD TO BE REPROCESSED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20362471 ↗MalfunctionJul 12, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE BRUISED THEIR ARM WHILE OPERATING AN AMSCO 7053HP WASHER/DISINFECTOR. THE EMPLOYEE DID NOT SEEK PROFESSIONAL MEDICAL ATTENTION AND INSTEAD SELF-TREATED BY APPLYING AN ICE PACK TO THEIR ARM.
Patient problems: Bruise/Contusion
MAUDE report 19732679 ↗MalfunctionSep 13, 2023Use 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. THE EMPLOYEE SELF-APPLIED AN ICE PACK, TOOK PAIN MEDICATION AND RETURNED TO WORK THE SAME DAY.
Patient problems: Bruise/Contusion
MAUDE report 17739049 ↗
Other Disinfector, medical devices devices
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- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
- GETINGE 86-SERIES S-8668Getinge Disinfection AB · Disinfector, Medical Devices1 recall37 reports
- Getinge Aquadis 56 56MGetinge Disinfection AB · Disinfector, Medical Devices1 recall11 reports
- AMSCO 7052HPCorporation Steris Canada · Disinfector, medical devices1 recall10 reports
- GETINGE 9100-SERIES 9128EGetinge Disinfection AB · Disinfector, Medical Devices1 recall10 reports
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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