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.
Mars Petcare has issued a voluntary recall for 22 bags of its Pedigree dog food that may contain small metal fragments and were sold at Dollar General stores in four states.
The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.
Days after Johnson & Johnson pulled its devices for minimally invasive hysterectomies from the global market, physicians are shedding light on alternative surgical methods and questioning the recall's implications for women undergoing the procedure.
The FDA issued a Class I recall status, its most serious, to medical device maker ConvaTec for its fecal management system that is blamed for one death and a dozen injuries. The company began its own recall of the system, which was not cleared for marketing by the FDA, in April.
Covidien has issued a recall of its Hydrofinity Hydrophilic Guidewire due to the potential for damage to the outer polymer jackets of the device during use. The company said it has notified the FDA of the action.
CareFusion's Alaris pump is again the subject of a recall, earning the FDA's most serious designation over a software problem that can muddle scheduled infusions and put patients at risk.
Add two more Abbott Laboratories diabetes products to the list of items deemed potentially deadly by the FDA. Five of the company's diabetes offerings have now been subject to the agency's most serious recall label in the past year.
"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal 's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.
Danish medical device maker Coloplast is said to have paid $16 million to settle lawsuits claiming it injured women with vaginal-mesh inserts. With settlement talk swirling around at least 5 more makers of the plagued devices, that has some watchers saying the time may be ripe for a global settlement.