STERRAD Cyclesure Biological Indicator — Class II medical device recall Z-0604-2014
Terminated recall by Advanced Sterilization Products, reported 2014-01-08. Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP
| Recall number | Z-0604-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-11-26 |
| Classified | 2013-12-28 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-03-05 |
| Lot numbers | 14913706, 15013706, 15413106, 15413706, 15513706, 15613706, 15713706, 15913706, 16113106, 16113706, 16213706, 16413706, 16413806, 16613706, 16813706, 16813806, 16913706, 17113706, 17213706, 17513706, 17613706, 17713706, 17813706, 17913706, 18013706, 18313706, 18413706, 18913706, 19013706, 19113706, 19213706, 19313706, 19613706, 19713706, 19813706, 19913706, 20013706, 20113706, 20313706, 20413706 and 45 more |
| Model numbers | 14324 |
Product
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Reason for recall
Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.
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-0604-2014. 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.