Packaging, software issues account for 40% of medical device recalls, report finds

The Q3 2014 Stericycle Recall Index highlights the complexities of medical device recalls in a global economy. With greater technology comes greater responsibility to consumers, and recalls that span different countries and continents add to companies' challenges. Packaging and software issues accounted for 40% of recalls that the Index covered. New developments include the FDA's unique device identification rule, aimed in part at improving recalls. "While the implementation of the UDI rule could ultimately improve many facets of recall execution, it also introduces an entirely new set of challenges for manufacturers and other stakeholders," said Stericycle vice president Mike Rozembajgier. "As manufacturers invest in technical innovations, recall planning and preparation cannot be overlooked. Failing to adapt recall planning accordingly is a critical mistake -- and one with potentially disastrous consequences." Release | Recall Index (PDF)

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.