Z-2276-2012Class II

CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The...

Name: Z-2276-2012 CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The...
Creator: Advanced Sterilization Products
Published: 2012-06-01
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2012-06-01 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and... on 2012-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2276-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Posted: 2012-08-27
Terminated: 2013-09-11
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.
Product code: MED Sterilant, Medical Devices
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,310,844 units
Distribution: Nationwide (USA) and Puerto Rico.
Product codes and lots: Product codes: 20390 (US).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2276-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2276-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

Product code MED

K030004Class II0.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products / cleared 2003-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)