FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: 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.
- Recall number
- Z-0661-2013
- Recalling firm
- Advanced Sterilization Products
- 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.
- Status
- Terminated
- Initiated
- 2012-09-20
- Posted
- 2013-01-09
- Terminated
- 2013-10-17
- 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.
- Root cause
- Labeling design
- Action
- Advanced Sterilization Product sent an Urgent Medical Device Recall (Removal) letter dated December 4, 2012, to all affected customers. The letter informed the customers that the Sterrad NX Cassettes do not have adequate data to support the entire duration of the product's labeled shelf-life. Customers are instructed of the problems identifed and the actions to be taken. Customers are instructed to notify their customers if they have further distributed the recalled products and to have them contact Stericycle at (877) 650-7686 to arrange for return of the product. Customers with questions are instructed to call Stericycle at (877) 650-7686 Mon-Fri from 8am to 5pm, ET. For questions regarding this recall call 949-453-6400.
- 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.
- Lot, serial or model codes
- Lot # 11J037, 11L038, 11J033
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLR
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28