Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps
Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.
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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a lack of data supporting packaging integrity, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 1,923 units of STERRAD 100NX Cassettes, Product Code 10144. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture-sensitive reusable medical devices.
The recall was initiated because ASP does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15-month shelf life. The affected cassettes were distributed nationwide in the United States and internationally to numerous countries, including Russia, Venezuela, Kuwait, Saudi Arabia, Hungary, the United Kingdom, Italy, and others.
Healthcare facilities and users of the STERRAD system should check their inventory for the specific lot numbers listed in the recall notice. If the cassettes are found, they should be removed from service and returned to Advanced Sterilization Products or their authorized distributor for replacement or refund, per the company's instructions.
The recalled product
- Product
- STERRAD 100NX Cassettes, Product Code: 10144 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
- 1,923
Distribution
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 integrity
See all →- HighCRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 8-10mm 240cm Medical Device Recall Notice
FDA (Devices) · 2026-07-08
- LowPopping Boba RTD Strawberry Dragon Fruit Oolong Tea packaging integrity issue
FDA (Food) · 2026-04-08
- LowPopping Boba Ready-to-Drink Mango Passion Fruit Green Tea Recall
FDA (Food) · 2026-04-08
- LowPopping Boba RTD Mixed Berry Hibiscus Tea Packaging Integrity Recall
FDA (Food) · 2026-04-08
Similar recalls
- ModerateAdvanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Defect
FDA (Devices) · 2014-12-31
- ModerateAdvanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue
FDA (Devices) · 2013-10-30
- ModerateAdvanced Sterilization Products Recalls STERRAD System Cassettes Due to Leak Indicator Defect
FDA (Devices) · 2014-12-31
- 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
- LowAdvanced Sterilization Products Recalls STERRAD 100S and NX Cassettes
FDA (Devices) · 2012-09-19