[Recalled] 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. — The recall was initiated because Adva

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Advanced Sterilization Products

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• STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments. — Class II
• STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. — Class II
• STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments. — Class II
• Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 — Class II
• STERRAD NX Sterilization System, Product Code: 10033, 10033-002 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.