STERRAD 200 Sterilization System — Class II medical device recall Z-1027-2013
Terminated recall by Advanced Sterilization Products, reported 2013-04-10, distributed nationwide. The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX a
| Recall number | Z-1027-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-03-22 |
| Classified | 2013-03-29 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2013-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,038 units |
Product
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Reason for recall
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems 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-1027-2013. 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.