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Embosphere® Microspheres-Syringe — recall 82504

Health Canada — Medical Devices · Canada · 2026-08-19 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
82504
Date of alert
2026-08-19
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Neurology
Product type
Medical devices
Reported risk: Merit Medical Systems, Inc., on behalf of its subsidiary, Biosphere Medical, is voluntarily recalling specific lots of the Merit Embosphere® Microspheres due to a supplier-related defect that may affect the device packaging sterile barrier. Specifically, certain lots provided to Merit may contain a hole in the blister packaging. Merit has chosen to remove the units from the market and request that customers immediately stop using or distributing the affected lots and return the affected product to Merit. According to Merit's evaluation of health hazard(s), use of the affected product may result in exposure to pathogens/pyrogens, which could lead to infection. To date, Merit has not received any complaints or reports of patient harm or injury associated with this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/embospherer-microspheres-syrin

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