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 | The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life. |
| Product | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. |
| Quantity | 1,923 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela. |
| Initiated | 2013-07-25 |
| Classified | 2013-09-10 |
| Terminated | 2013-11-27 |
| Recall number | Z-2174-2013 |
| 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-2174-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65957/
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.