FDA in recent months has announced Class I recalls covering hundreds of thousands of medical devices.
From crack-prone catheters to high-tech trouble, here’s a rundown of the most serious and/or widespread recalls:
1. A Massive Glucose Monitor Recall
Dexcom announced a massive continuous glucose monitor recall, involving more than 260,000 devices with alarms that may fail to sound. Rather than asking customers to return the devices, the San Diego company sent patients a letter February 23 listing instructions on how to test the receiver’s audio alert. The company said that customers had complained that the speakers failed to provide audible alerts and alarms “in some or all circumstances,” but did not explain what went wrong.
