AMSCO 7053L (REF FH41)Recalls & reported problems
Corporation Steris Canada · The AMSCO 7053L Single-Chamber Washer/Disinfector meets the demands for the highest-volume sterile processing departments. It 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
- 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 00724995152079), received between Apr 4, 2025 and Apr 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Smoking; Smoking
THE USER FACILITY REPORTED THAT THEIR AMSCO 7053L SINGLE-CHAMBER WASHER-DISINFECTOR EMITTED SMOKE DURING A CYCLE. THE POWER TO THE UNIT WAS SHUT OFF. NO REPORT OF INJURY; HOWEVER, THE FACILITY REPORTED THAT PROCEDURES HAD TO BE POSTPONED DUE TO THE SPREAD OF SMOKE WITHIN THE SURGICAL DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857975 ↗MalfunctionApr 4, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THEIR AMSCO 7053L SINGLE-CHAMBER WASHER-DISINFECTOR WAS LEAKING LIQUID ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773491 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.