Steris Recalls AMSCO Steam Sterilizers Due to Software Defect
Steris is recalling 701 AMSCO C and AMSCO 400 steam sterilizers because a software defect may interrupt processing cycles, causing procedure delays.
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. The identified hazard is a software defect causing procedure delays rather than direct physical injury or contamination, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Steris Corporation is recalling 701 units of AMSCO C and AMSCO 400 steam sterilizers. These devices are designed for the sterilization of heat and moisture-stable materials used in healthcare facilities. The affected models include the AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, and AMSCO 400 Medium Sterilizer.
The recall was initiated because the control board software in select units may interrupt and cancel a processing cycle if the selected sterilizer shutdown time coincides with an active cycle. This defect may result in a delay to the sterilization procedure.
The affected units were distributed worldwide, including in the United States and in Afghanistan, Canada, Japan, Kuwait, Mexico, the Republic of Korea, and the United Arab Emirates. Users should contact Steris Corporation for further instructions regarding the recall.
The recalled product
- Product
- AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
- Manufacturer
- Steris Corporation
- Affected units
- 701
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 (2)
- AMSCO 400 Units: Serial #'s: 030051501 - 033641440
- AMSCO C Units: Serial #'s: R020051501 - R023641403.
Distribution
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