Steris Reliance 130 Cart Washer Recall for Door Safety Feature Installation
Steris is recalling 367 Reliance 130 and 130L Cart Washers to install a door close confirmation button and door open delay to ensure proper operation.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a procedural update to ensure proper operation rather than a defect causing injury or death, aligning with the criteria for moderate severity involving low-risk issues or voluntary precautionary measures.
Plain-English summary
Steris Corporation is recalling 367 units of the Reliance 130 and 130L Cart Washer/Disinfector. These high-capacity mechanical washers are used in healthcare facilities to wash, low-level disinfect, and dry carts, utensils, beds, and other reusable items used in patient care.
The recall is being conducted to ensure that users are properly operating the equipment. As part of the recall, a door close confirmation button and a door open delay will be installed on the affected cart washers. The agency has classified this as a Class II recall.
The affected units were distributed nationwide in the United States and internationally in Australia, South Korea, France, Italy, Lebanon, Russia, Saudi Arabia, Spain, the UAE, the United Kingdom, and Canada. Healthcare facilities should contact Steris Corporation to arrange for the installation of the required safety features.
The recalled product
- Product
- The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities…
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 367
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)
- on the 64th day of the year of 1999
Distribution
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