—#217381

Product

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

FDA product code: MEC — Disinfector, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Code: UDI: 00724995176662, 00724995176679, 00724995176655 Serial numbers of distributed units: 3619725008, 3619725011, 3619725013, 3621625010, 3621625011, 3621625013, 3621625014, 3621625015, 3621925001, 3621925002, 3621925005, 3621925010, 3622425005, 3622725005, 3622725011, 3622725012, 3623125006, 3623425016, 3623825008, 3624025002, 3624025008, 3624525007

Why it was recalled

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).

Root cause (FDA determination)

Process control

Action the firm took

On November 19, 2025, firm began notifying customers via Urgent Medical Device Field Correction letters. All affected customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their units to perform the correction. If the affected unit has not been installed yet, the correction will be performed as part of the installation process. Users can continue to use their units prior to completion of the correction. Under normal operation, the system is designed to detect such electrical arcing specifically, indicating a Drying Over Temperature Switch Tripped alarm. Should your unit alarm, abort the cycle, turn off power to the unit, and contact STERIS.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.

Timeline

Recall initiated: 2025-11-19
Posted by FDA: 2025-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217381. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.