FDA Device recall Z-2276-2012
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution
- FDA Device
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution by Advanced Sterilization Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2276-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-01 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
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
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.
Identifiers
| code_info | Product codes: 20390 (US). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Advanced Sterilization Products
- STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA Device · Class II · 2017-02-22 · Advanced Sterilization Products - EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi…
FDA Device · Class II · 2017-01-18 · Advanced Sterilization Products - CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
FDA Device · Class II · 2015-09-23 · Advanced Sterilization Products - CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA Device · Class II · 2015-09-02 · Advanced Sterilization Products - Wall Chart for STERRAD 100NX System, P/N 10104
FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products
All Advanced Sterilization Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2276-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.