AMSCO 1215 (REF FW12101)Recalls & reported problems
Corporation Steris Canada · AMSCO 1215 Cart and Utensil Washer/Disinfector, 200-208V, 60hz, Steam Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers. · Class 2
All models of AMSCO (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995214395), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.
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. 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
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Leak/Splash; Leak/Splash
THE USER FACILITY OBSERVED THAT A "FLY" WAS PRESENT BETWEEN THE GLASS PANELS OF THEIR AMSCO 1215 CART WASHER/DISINFECTOR. USER FACILITY PERSONNEL ELECTED TO REMOVE THE UNIT FROM SERVICE AND POSTPONE PATIENT PROCEDURES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20250578 ↗
Other Disinfector, medical devices devices
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls6 reports
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls0 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls3 reports
- 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
- GETINGE 9100-SERIES 9128EGetinge Disinfection AB · Disinfector, Medical Devices1 recall10 reports
- 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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