STERRAD 100S Cassette — Class III medical device recall Z-2337-2012
Terminated recall by Advanced Sterilization Products, reported 2012-09-19, distributed nationwide. Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes
| Recall number | Z-2337-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2012-06-19 |
| Classified | 2012-09-07 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2013-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 7,495 units |
| Lot numbers | 12A077 |
Product
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and 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 Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Reason for recall
Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
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-2337-2012. 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.