The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1595-2023·Announced 2023-05-24

Steris Reliance Vision Washer/Disinfector Recalled for Fire and Smoke Risk

Steris is recalling 322 Reliance Vision Multi-Chamber Washer/Disinfectors because an electrical contactor malfunction could cause heating elements to overheat and produce smoke or fire.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is a Class II medical device recall involving a potential fire and smoke hazard. No injuries, fires, or property damage have been reported; the hazard is theoretical and described as a 'remote occurrence.' Per the severity rubric, risk-of-harm products with injury not yet reported score 3 (High).

Plain-English summary

Steris Corporation is recalling the Reliance Vision Multi-Chamber Washer/Disinfector (Reference Number FH83062) due to a potential electrical hazard in the drying chamber.

If the electrical contactor component in the drying chamber malfunctions, the heating elements could overheat, potentially resulting in smoke and/or fire.

Approximately 322 units have been distributed worldwide, including to customers in the United States, China, Lithuania, Saudi Arabia, South Korea, Canada, Taiwan, the United Kingdom, Spain, Australia, New Zealand, Brazil, Bahrain, Switzerland, South Africa, Hong Kong, and Qatar. Consumers and healthcare facilities with affected units should contact Steris Corporation for guidance.

The recalled product

Product
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Manufacturer
Steris Corporation
Category
Medical Device — Cleaning and Sterilization Equipment
Hazard
Affected units
322

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00724995193164

Distribution

Distributed nationwide across the United States.

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