STERRAD NX Cassettes — Class II medical device recall Z-0661-2013
Terminated recall by Advanced Sterilization Products, reported 2013-01-16, distributed nationwide. Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not hav
| Recall number | Z-0661-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2013-01-09 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2013-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 12,280 units |
| Reason classes | labeling |
| Lot numbers | 11J033, 11J037, 11L038 |
Product
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Reason for recall
Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled 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-0661-2013. 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.