STERRAD CYCLESURE 24 Biological Indicator — Class II medical device recall Z-1180-2013
Terminated recall by Advanced Sterilization Products, reported 2013-05-08, distributed nationwide. Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product
| Recall number | Z-1180-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-04-22 |
| Classified | 2013-04-26 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2013-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 69,994 cases |
| Reason classes | labeling |
| Lot numbers | 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127, 039127, 040127, 041121, 042127, 043127, 044127, 045121, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127 and 146 more |
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Reason for recall
Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product 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-1180-2013. 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.