FDA Device recall Z-1026-2013
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature s…
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature s… 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-1026-2013 |
| 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 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX 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 | SO Numbers: 601918 601921 653618 658412 658619 663775 663605 670265 670983 676483 676976 677247 682484 68…SO Numbers: 601918 601921 653618 658412 658619 663775 663605 670265 670983 676483 676976 677247 682484 683535 683401 685051 684706 684897 689791 693170 688731 695253 685242 695044 694872 694890 694933 700374 700420 687958 695322 698794 694561 696647 694903 697444 703236 704953 705019 704220 704997 684009 705131 705189 705395 706157 707254 707928 709374 710904 705394 710055 710381 711947 712233 712952 711466 713603 714781 714896 714927 714941 715465 714230 714936 715319 715471 680655 711359 715140 704508 715994 716005 715655 716503 716506 716482 716806 716925 716956 716977 717350 716504 717332 717457 717466 717456 717490 716774 717477 717487 717482 717472 716955 723403 718518 724650 717455 727905 717473 732354 726771 733003 733007 732940 735456 736315 736250 742622 742112 742351 740419 739924 747572 746618 746545 747670 747711 748911 734951 752042 752042 755131 752 |
|---|
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-1026-2013%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.