Class II — Advanced Sterilization Products
| Recalling firm | Advanced Sterilization Products |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 1,305 units total (654 units in US , 651 OUS ) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada |
| Initiated | 2013-09-18 |
| Classified | 2013-10-22 |
| Terminated | 2014-04-11 |
| Recall number | Z-0043-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advanced Sterilization Products (Z-0043-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66328/
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