Steris Recalls AMSCO Steam Sterilizers Due to Foot Pedal Software Issue
Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a software defect affecting a mechanical function (door operation) rather than a direct safety hazard like fire or injury.
Plain-English summary
Steris Corporation is recalling 32 units of AMSCO 400 and AMSCO C Small Steam Sterilizers. The recall affects units equipped with the CS-iQ feature that were distributed nationwide in the United States.
The recall is due to a software defect that inadvertently prevents the foot pedal from operating. This issue stops the operator from using the foot pedal to open and close the sterilizer door. The agency has classified this recall as Class III.
Consumers and healthcare facilities should identify their units by checking the serial numbers against the list provided in the official recall notice. Affected serial numbers include 033331205, 033341248, and others listed in the source document. Users should contact Steris Corporation for instructions on how to resolve the software issue.
The recalled product
- Product
- AMSCO 400 and AMSCO C Small Steam Sterilizers
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Sterilizer
- Affected units
- 32
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 (20)
- Serial #'s: 033331205
- 033341248
- 033351210
- 033401221
- 033411215
- 033451217
- 030741306
- 031491314
- 032381302
- 032341304
- 033281222
- 030621412
- 030871412
- 030871410
- 031751401
- 031771425
- 031781412
- 031781414
- 031911436
- R020141502
Distribution
Distributed nationwide across the United States.
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