CIDEX OPA, High Level Disinfectant Solution… recallZ-2276-2012 · Advanced Sterilization Products · initiated Jun 1, 2012
Class II Terminated All recalls posted in August 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Sterilization Products or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
An "Urgent Medical Device Recall" letter dated August 10, 2012 was sent to all customers who purchased the CIDEX OPA solution, part #20390 (manufactured between May 2011 and April 2012). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to notify their customers if they have distributed bottles of CIDEX OPA Solution to other locations. Customers were instructed to call Stericycle at (866) 629-6182 to arrange for return of the product.
Recall details
- Recall number
- Z-2276-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 1, 2012
- Posted by the FDA
- Aug 27, 2012
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 1,310,844 units
- Product code
- MED
- FDA submissions
- K030004
- Distribution
- Nationwide (USA) and Puerto Rico.
Product description
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.
Code information (models, lots, serial numbers)
Product codes: 20390 (US).
Other devices under the same FDA submission
1 device cleared under K030004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CIDEX™ 20390Advanced Sterilization Products Services Inc. · Sterilant, medical devices33 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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