Recall Z-1256-2022— Steris Corporation

Name: FDA recall Z-1256-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-22

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2022-04-22, terminated 2024-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Reliance Synergy Washer/Disinfector. Reason: The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2022-04-22
Terminated: 2024-11-04
Firm location: Mentor, OH, United States

Product description

Reliance Synergy Washer/Disinfector

Reason for recall

The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Data sourced from openFDA. This site is unofficial and independent of the FDA.