Embosphere® Microspheres-Syringe

Issue

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.