AMSCO 7053L (REF FH41042)Recalls & reported problems
Corporation Steris Canada · The AMSCO 7053L Single-Chamber Washer-Disinfector, Steam Unit is designed for cleaning and intermediate-level disinfection of soiled reusable utensils, trays, bedpans and urinals. It can also be used for rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps) and other similar and related articles found in healthcare facilities. · Class 2
All models of AMSCO (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995193096), received between Mar 5, 2025 and Jul 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Leak/Splash1
Patient problems
- Laceration(s)1
- 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.
MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A HAND INJURY WHILE UNLOADING AN INSTRUMENT RACK FROM THEIR AMSCO 7053L SINGLE-CHAMBER WASHER/DISINFECTOR. THE EMPLOYEE RECEIVED MEDICAL TREATMENT.
Patient problems: Laceration(s)
MAUDE report 22587056 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR RELIANCE SYNERGY WASHER/DISINFECTOR WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529093 ↗
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- AMSCO 7053HPCorporation Steris Canada · 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 14, 2026 · each report above links to its original FDA record
- 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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