Advanced Sterilization Products Recalls STERRAD 100S Cassettes for Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 100S 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. The hazard involves a packaging indicator that may not function properly, which is a functional defect but does not explicitly report hospitalizations or significant injuries, fitting the Moderate criteria for a Class II recall without severe reported harm.
Plain-English summary
Advanced Sterilization Products is recalling STERRAD 100S cassettes (Product Code 10113) due to a defect in the packaging. The leak indicator on the cassettes 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. A total of 19,978 units were distributed worldwide, with 9,792 units distributed in the United States.
The source text does not specify specific actions for consumers or healthcare facilities, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- STERRAD 100S, Product Code 10113. 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
Same manufacturer · Advanced Sterilization Products
See all →- HighAdvanced Sterilization Products Recalls STERRAD NX Sterilization Systems
FDA (Devices) · 2017-02-22
- ModerateASP Recalls EVOTECH Endoscope Cleaner Due to Hose Leak Risk
FDA (Devices) · 2017-01-18
- ModerateAdvanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling
FDA (Devices) · 2015-09-23
- ModerateAdvanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution
FDA (Devices) · 2015-09-02
- ModerateAdvanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions
FDA (Devices) · 2015-08-19
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateAdvanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue
FDA (Devices) · 2013-10-30
- ModerateAdvanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps
FDA (Devices) · 2013-09-18
- LowAdvanced Sterilization Products Recalls STERRAD 100S and NX Cassettes
FDA (Devices) · 2012-09-19
- LowAdvanced Sterilization Products Recalls STERRAD NX Cassettes Due to Printing Verification Failure
FDA (Devices) · 2012-09-19
- ModerateAdvanced Sterilization Products Recalls STERRAD NX Cassettes Due to Shelf-Life Data
FDA (Devices) · 2013-01-16
- ModerateAdvanced Sterilization Products Recalls STERRAD Sterilization Systems
FDA (Devices) · 2013-12-04