Recall Z-0909-2026 ยท MEC Disinfector, Medical Devices
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 sh
| Date | Dec 11, 2025 (initiated Nov 19, 2025) |
| Status | Open, Classified |
| 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 alar |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.