The Recall Desk
HighFDA (Devices)·Z-1256-2022·Announced 2022-06-15

Reliance Synergy Washer/Disinfector fire hazard due to electrical contactor malfunction

Steris Corporation is recalling Reliance Synergy Washer/Disinfector units due to a malfunctioning electrical contactor that can cause heating elements to overheat, creating a fire risk. Affected units may generate smoke and fire in the drying chamber.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential fire and overheat hazard in the drying chamber due to electrical contactor malfunction; no reported illnesses or injuries.

Plain-English summary

Steris Corporation is recalling Reliance Synergy Washer/Disinfector units nationwide and internationally. The recall affects approximately 3,863 units (2,776 in the US and 1,087 outside the US). The affected serial numbers are listed by the FDA.

The electrical contactor component in the drying chamber of affected units may malfunction. When this occurs, the heating elements in the drying chamber can overheat, potentially resulting in smoke and/or fire.

These medical devices have been distributed nationwide in the US and to other countries worldwide. Healthcare facilities and organizations using these devices should check the provided serial numbers to determine if their equipment is affected.

Users should immediately stop using affected units and contact Steris Corporation for service or replacement. Do not attempt to repair or operate units if you suspect the electrical contactor component is malfunctioning.

The recalled product

Product
Reliance Synergy Washer/Disinfector
Manufacturer
Steris Corporation
Category
Medical Device
Hazard

Distribution

Distributed nationwide across the United States.

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