FDA-Device2025-12-17Class IIPROCESSING DEFECT

Steris AMSCO 7052HP Washer/Disinfector recalled for internal electrical arcing hazard

ELECTRICAL SHOCKFIRENationwide distributionMedical devicesBaby & kids

What this means

A wire in the electrical box of the AMSCO 7052HP Washer/Disinfector may shift out of position, causing electrical arcing inside the unit. The arcing occurs internally and does not pose a shock risk to users, but could affect equipment function or safety.

  • Check if your facility has a unit matching serial numbers 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, or 3624525002
  • Contact Steris Corporation for instructions on inspection or repair
  • Do not discontinue use unless instructed by Steris
The agency's original wording
Hazard

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).

Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
10
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2026

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