FDA Device recall Z-0402-2014
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat… by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyureth….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0402-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-11 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason
Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.
Identifiers
| code_info | Please refer to consignee list |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Advanced Sterilization Products
- STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA Device · Class II · 2017-02-22 · Advanced Sterilization Products - EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi…
FDA Device · Class II · 2017-01-18 · Advanced Sterilization Products - CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
FDA Device · Class II · 2015-09-23 · Advanced Sterilization Products - CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA Device · Class II · 2015-09-02 · Advanced Sterilization Products - Wall Chart for STERRAD 100NX System, P/N 10104
FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products
All Advanced Sterilization Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0402-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.