CIDEX OPA — Class II medical device recall Z-2276-2012
Terminated recall by Advanced Sterilization Products, reported 2012-09-05, distributed nationwide. The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on
| Recall number | Z-2276-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2012-06-01 |
| Classified | 2012-08-27 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2013-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,310,844 units |
| Reason classes | labeling |
Product
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Reason for recall
The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.
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-2276-2012. 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.