Advanced Sterilization Products CIDEX OPA Solution, ortho-Phthalaldehyde Solution Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CIDEX OPA Solution, ortho-Phthalaldehyde Solution
Brand
Advanced Sterilization Products
Lot Codes / Batch Numbers
Product Code: 20390, 20391, 20394
Products Sold
Product Code: 20390, 20391, 20394
Advanced Sterilization Products is recalling CIDEX OPA Solution, ortho-Phthalaldehyde Solution due to Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
Recommended Action
Per FDA guidance
Firm conducted WebEx meeting with affiliates on April 12 & 13, 2004 to discuss CIDEX OPA Solution labeling. April 23, 2004, Firm sent letters to affiliates, customers, and end users to notify of new contraindication for CIDEX OPA Solution. Same letter was sent to U.S. Healthcare facilities on April 23, 2004; to Urology M.D.s on April 28, 2004; to Urologist Nurses on May 7, 2004. Customers can call 800-370-4632 with questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026