Advanced Sterilization Products: Medical Device Recall in 2012 - (Recall #: Z-2276-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 1, 2012

Date Posted: September 5, 2012

Recall Number: Z-2276-2012

Event ID: 62919

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.

Status: Terminated

Product Quantity: 1,310,844 units

Code Information:

Product codes: 20390 (US).

Distribution Pattern:

Nationwide (USA) and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated