FDA Device recall Z-0746-2014
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature steriliz…
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature steriliz… by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells poss….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0746-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-16 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Reason
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
Identifiers
| code_info | not available |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2014%22
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