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AMSCO 1215 (REF FW12112)Recalls & reported problems

Corporation Steris Canada · AMSCO 1215 Cart and Utensil Washer/Disinfector, 460-480V, 60hz, Electric Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers. · Class 2

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 00724995214418), received between Apr 1, 2026 and Apr 1, 2026 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Headache1
  • Swelling/ Edema1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 1, 2026Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS LOADING THEIR AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR, THE TOP PANEL FELL AND CONTACTED THE EMPLOYEE'S HEAD. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND RECEIVED A CT SCAN WHICH CONFIRMED NO FURTHER INJURIES OR MEDICAL TREATMENT REQUIRED. THE EMPLOYEE RETURNED TO WORK.

    Patient problems: Headache; Swelling/ Edema

    MAUDE report 24760076 ↗

Other Disinfector, medical devices devices

All Disinfector, medical devices devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.