Steris Recalls Amsco Steam Sterilizers Due to Erroneous Alarm Activation
Steris Corporation is recalling Amsco C and Amsco 400 steam sterilizers because control board defects cause erroneous alarms that lock up the devices.
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 explicitly describes the hazard as 'Customer nuisance' caused by device lock-up, with no reports of injury, illness, or serious harm, fitting the criteria for a moderate severity score.
Plain-English summary
Steris Corporation is recalling 395 units of Amsco C and Amsco 400 steam sterilizers. These devices are designed for the sterilization of heat and moisture-stable materials in healthcare facilities. The recall covers units distributed worldwide, including the United States, Canada, and specific U.S. states.
The recall was initiated because the control board's alarm set points and temperature tolerances allowed for the erroneous activation of the analog/digital alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until it is serviced, causing nuisance to customers.
Affected units include Amsco C models with serial numbers 021911201 through 023461202 and Amsco 400 models with serial numbers 030181215 through 030291310. Users should check their serial numbers against this list. The source text does not specify further consumer actions beyond the implication that the devices require servicing to resolve the lock-up issue.
The recalled product
- Product
- AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
- Manufacturer
- Steris Corporation
- Affected units
- 395
Distribution
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