STERRAD CYCLESURE 24 Biological Indicator — Class II medical device recall Z-0520-2013
Terminated recall by Advanced Sterilization Products, reported 2012-12-19, distributed nationwide. Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI)
| Recall number | Z-0520-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2012-10-03 |
| Classified | 2012-12-12 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2013-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 38,532 units |
| Reason classes | labeling |
| Lot numbers | 003117, 004101, 004117, 005101, 005118, 00591Z, 006117, 00691Z, 007101, 008101, 00891Z, 00991Z, 010117, 011101, 011117, 012101, 012117, 01219Z, 013101, 013117, 014101, 014117, 01419Z, 015101, 015107, 016117, 01691Z, 018101, 019101, 01991Z, 020117, 020118, 021101, 021107, 021117, 022101, 023101, 024117, 025107, 025117 and 460 more |
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is 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 all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.
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-0520-2013. 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.