Advanced Sterilization Products Recalls STERRAD 50 Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 50 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging defect (leak indicator failure) that poses a theoretical risk to sterilization integrity, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advanced Sterilization Products is recalling STERRAD 50 cassettes (Product Code 10114) because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide. The STERRAD Cassettes are used on the STERRAD Sterilization System, which is a low-temperature general-purpose sterilizer used to sterilize heat and moisture-sensitive reusable medical devices.
The recall involves 19,978 units total, with 9,792 units distributed in the US and the remainder distributed worldwide. The specific lot codes affected are listed in the structured product information. No illnesses or injuries have been reported in the source text.
Healthcare facilities and consumers should stop using the affected cassettes and contact Advanced Sterilization Products for instructions on return or replacement. The defect affects the packaging's ability to indicate a leak, which may compromise the integrity of the sterilization process for the devices inside.
The recalled product
- Product
- STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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