As summer comes to a close, medical device recalls remain at an all-time high. In total, almost half of medical device recalls reported in Q2 of this year contained both international and domestic components. In addition, total recalls increased 30% over the first quarter of the year, indicating that recalls are increasing in frequency. Based on this, it’s essential for manufacturers to have a solid understanding of regulatory environments where products are marketed.
"Safety in global distribution and supply chains has no boundaries. Companies should implement recall plans that prepare for the increased complication and regulatory oversight that they or their vendors will have to navigate during an international product recall,” noted Mike Rozembajgier, VP of Stericycle ExpertRECALL.
Here, we recap the recalls that FDA worthy of the Class I designation, which pose a significant risk of causing serious health problems or death to patients. In addition, we also included a recently-announced voluntary recall.