STERRAD 100NX Cassettes — Class II medical device recall Z-2174-2013
Terminated recall by Advanced Sterilization Products, reported 2013-09-18, distributed nationwide. The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not
| Recall number | Z-2174-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-07-25 |
| Classified | 2013-09-10 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2013-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, GB, IL, PA, QA, SI, VE |
| Quantity | 1,923 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10104001070035, 10104001070042, 10104001070059, 10104001080027, 10104001080034, 10104001080041, 10104001080058, 10104001080065, 10104001080072, 10104001080089, 10104001080096 |
| Lot numbers | 1041070025, 1041070026, 1041070047, 1041070146, 1041070147, 1041070148, 1041070149, 1041070150, 1041070151, 1041070152, 1041070153, 1041070154, 1041070155, 1041070156, 1041080082, 1041080194, 1041080196, 1041080200, 1041080201, 1041080202, 1041080203, 1041080204, 1041080205, 1041080206, 1041080207, 1041080211, 1041080212, 1041080213, 1041080214, 1041080215, 1041080216, 1041080217, 1041080218, 1041080219, 1041080220, 1041080221, 1041080224, 1041080225, 1041080226, 1041080228 and 460 more |
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.
Reason for recall
The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (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.
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-2174-2013. 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.