FDA Device recall Z-1027-2013
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature steri…
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature steri… by Advanced Sterilization Products, citing the recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1027-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-22 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Reason
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Identifiers
| code_info | Codes: 10217 10201-002 10201 10202-001 |
|---|
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-1027-2013%22
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