Z-0909-2026Class II

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP...

Name: Z-0909-2026 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP...
Creator: Steris Corporation
Published: 2025-11-19
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2025-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Steris Corporation began a recall of AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and... on 2025-11-19. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0909-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-19
Posted: 2025-12-11
Recalling firm: STERIS Corporation
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.
Product code: MEC Disinfector, Medical Devices
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 10
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.
Product codes and lots: Lot Code: UDI:00724995176587, 00724995176594, 00724995176570 Serial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0909-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0909-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0910-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)