Medical Product Alert N°1/2026: Substandard ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol)
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Published on May 7, 2026.
The WHO Medical Product Alert has been issued for the first time since March 2026, concerning a Class I quality defect affecting batches of iodinated contrast media (Iohexol or Iodixanol) marketed under the brand names ACCUPAQUE, OMNIPAQUE and VISIPaQUE. The product was manufactured by GE HealthCare Ireland Limited and distributed globally to multiple countries. The defect involves the presence of metallic particulate matter, either adhered to or embedded within the inner surface of polypropylene bottles, which can cause serious adverse events including life-threatening embolic events. The affected batches have been supplied globally to hospitals performing interventional radiology, cardiology procedures, and vascular surgery procedures. The risk of contamination is higher in settings where visual inspection of products is not strictly performed, or where alternative contrast agents are unavailable. WHO advises national regulatory authorities and health-care professionals of the potential risk associated with metallic particulates. The Alert also urges the public to be vigilant for adverse events potentially related to particulate embolism, which may occur when solid particles enter the bloodstream and obstruct small blood vessels, leading to impaired blood flow and ischemic injury.
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