Steris SYSTEM 1E Liquid Chemical Sterilant Processing System Recalled for Valve Issues
Steris Corporation is recalling SYSTEM 1E Liquid Chemical Sterilant Processing Systems because check valve o-rings degrade, causing nuisance aborts.
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 reported issue is 'nuisance aborts' due to mechanical degradation, which is a functional defect rather than a direct safety hazard like a structural failure or contamination risk, fitting the Moderate category for low-risk or precautionary issues.
Plain-English summary
Steris Corporation is recalling 6,028 units of the SYSTEM 1E Liquid Chemical Sterilant Processing System, Models 6500 and 7500. The system is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat-sensitive medical devices, including endoscopes and their accessories.
The recall was initiated because customers reported fluctuations in environmental conditions and gradual degradation or deformation of check valve o-rings following frequent contact with S40 sterilant use solution. These issues result in nuisance aborts during the sterilization process.
The affected products were distributed nationwide in the United States, the District of Columbia, and Puerto Rico. The product was also shipped to Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey, and the United Kingdom. Users should contact Steris Corporation for further instructions regarding the recall.
The recalled product
- Product
- SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and…
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 6,028
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)
- Model #6500 & 7500
Distribution
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