STERRAD NX Sterilization System — Class II medical device recall Z-1197-2017
Terminated recall by Advanced Sterilization Products, reported 2017-02-22, distributed nationwide. Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external p
| Recall number | Z-1197-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2017-01-09 |
| Classified | 2017-02-14 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, EC, EG, ES, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IT, JP, KR, LK, MX, MY, NL, NZ, PA, PE, PH, PL, PT, QA, SA, SE, SG, SI, TH, TR, TW, UY, VE, VN, ZA |
| Serial numbers | 10033050160, 10033050180, 10033050183, 10033050184, 10033050185, 10033050188, 10033050205, 10033050216, 10033050217, 10033050218, 10033050219, 10033050220, 10033050225, 10033050230, 10033050238, 10033050248, 10033050249, 10033050252, 10033050253, 10033050271, 10033050273, 10033050279, 10033050284, 10033050287, 10033050291 and 475 more |
Product
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1197-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.