FDA recall Z-0909-2026

Steris Corporation · Class II · device

Product

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.

Reason for recall

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).

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-11-19
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mentor, OH, United States

Primary source

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