STERRAD 100NX Cassettes The STERRAD Sterilization System is a low… — Class II medical device recall Z-0044-2014
Terminated recall by Advanced Sterilization Products, reported 2013-10-30, distributed nationwide. Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Casse
| Recall number | Z-0044-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-09-18 |
| Classified | 2013-10-22 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 2,995 units |
| Reason classes | labeling, packaging |
| Lot numbers | 13F049, 13F050, 13F051 |
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.
Reason for recall
Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0044-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.