Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue
Advanced Sterilization Products is recalling STERRAD 100NX Cassettes because the leak indicator is effective for only 12 months, not the labeled 15 months.
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: This is an FDA Class II recall involving a labeling/shelf-life discrepancy regarding the leak indicator. No illnesses or injuries are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling three lots of STERRAD 100NX Cassettes. The affected lots are 13F049, 13F050, and 13F051. These cassettes are used in the STERRAD Sterilization System, a low-temperature general-purpose sterilizer for heat and moisture-sensitive reusable medical devices.
ASP determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life. This discrepancy means the indicator may not function as intended during the final three months of the product's stated shelf life.
A total of 2,995 units were distributed nationwide. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 2,995
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 (3)
- Lot# 13F050
- 13F051
- 13F049
Distribution
Distributed nationwide across the United States.
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