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 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. |
| 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. |
| Quantity | 12,280 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB. |
| Initiated | 2012-09-20 |
| Classified | 2013-01-09 |
| Terminated | 2013-10-17 |
| Recall number | Z-0661-2013 |
| 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-0661-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63877/
Alerts for Advanced Sterilization Products
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.