Steris Corporation recalls AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description:…
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).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP 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 facilitiesUDI 0072499517666225 affected lots00724995176662007249951766790072499517665536197250083619725011361972501336216250103621625011
+17 more
36216250133621625014362162501536219250013621925002362192500536219250103622425005362272500536227250113622725012362312500636234250163623825008362402500236240250083624525007
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0910-2026
- FDA device classification · MECOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.6992The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Steris CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
