RecallRadar

FDA Device recall Z-2276-2012

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

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

AgencyFDA Device
Recall numberZ-2276-2012
ClassificationClass II
Statusterminated
Initiated2012-06-01
Published2012-09-05
Last updated2026-09-13 11:53 UTC
CompanyAdvanced Sterilization Products
DistributionUS

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_infoProduct 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.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2276-2012%22

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