AMSCO 7053HP (REF FH19043)Recalls & reported problems
Corporation Steris Canada · The AMSCO 7053HP Washer-Disinfector with Electric 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995176679), received between May 14, 2025 and Jul 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Leak/Splash1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Detachment of Device or Device Component
The user facility reported while an employee was cleaning their AMSCO 7053HP Washer/Disinfector the panel that cover's the facility's plumbing/water inlet adjacent to the unit detached and "struck" the employee on the arm. It is unknown if medical treatment was sought or administered.
Patient problems: Insufficient Information
MAUDE report 50082608 ↗MalfunctionMay 14, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THEIR AMSCO 7053HP WASHER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021695 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.