AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect
Summary
The FDA issued a Class II for AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Descri by Steris Corporation. Reason: Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal.
Details
Source
Device Recall
External ID
Z-0909-2026
Action Date
2025-12-17
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Lot Code: UDI:00724995176587, 00724995176594, 00724995176570 Serial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002
Quantity Affected: 10
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-19
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0909-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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