RecallRadar

FDA Device recall Z-1197-2017

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

On 2017-02-22 the FDA classified a Class II recall of STERRAD NX Sterilization System, Product Code: 10033, 10033-002 by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged durin….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1197-2017
ClassificationClass II
Statusterminated
Initiated2017-01-09
Published2017-02-22
Last updated2026-09-13 11:54 UTC
CompanyAdvanced Sterilization Products
DistributionUS

Product

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

Reason

Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.

Identifiers

code_info
Serial No 33100270 33110267 10033070599 33110166 33102348 10033070293 10033070296 10033070115 10033060166 331…Serial No 33100270 33110267 10033070599 33110166 33102348 10033070293 10033070296 10033070115 10033060166 33111764 33120476 10033050564 33130497 10033070381 10033070382 10033060659 33101036 33110266 33110308 33101084 33101087 33120355 33110445 33120379 1033160123 33101078 10033060377 33090564 33081028 33120585 33090532 10033060637 33130516 33110446 33110894 33111832 33111336 33111363 33111573 33111580 33110148 33101330 33120120 10033060898 33100023 33090562 33101545 33101573 33090528 10033070039 10033060706 33100367 10033050651 10033050652 10033050653 10033060178 10033070271 33110891 33120063 33111632 33081444 33081449 33111445 33101574 33120131 33130325 10033080299 33101333 33101352 1033142129 33130407 33111725 10033060230 33111710 33120162 33120165 33110448 33110454 10033080184 10033080185 10033080035 33101110 33101113 33101121 10033070022 10033070023 10033070026 10033070143 10033070144 10033070

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1197-2017%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.