FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: 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.
- Recall number
- Z-2276-2012
- Recalling firm
- Advanced Sterilization Products
- 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.
- Status
- Terminated
- Initiated
- 2012-06-01
- Posted
- 2012-08-27
- Terminated
- 2013-09-11
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 1,310,844 units
- Distribution
- Nationwide (USA) and Puerto Rico.
- Lot, serial or model codes
- Product codes: 20390 (US).
- 510(k) numbers
- ["K030004"]
- PMA numbers
- not on file
- Product code
- MED
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28