FDA Medical Device Recalls (openFDA)
Steris Corporation: 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.
- Recall number
- Z-0909-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2025-11-19
- Posted
- 2025-12-11
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Code: UDI:00724995176587, 00724995176594, 00724995176570 Serial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28