STERRAD 200 Sterilizer — Class II medical device recall Z-0043-2014
Terminated recall by Advanced Sterilization Products, reported 2013-10-30, distributed nationwide. Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an
| Recall number | Z-0043-2014 |
|---|---|
| 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 | 2014-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Model numbers | 10201, 10202 |
Product
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. 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 STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
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-0043-2014. 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.