During the period covered by the report ('05-'09), medical-device makers initiated 3510 device recalls, which cover everything from "field corrections" to revised labeling to retrieving a device from customers. The agency categorized about 83% of these recalls as class II, indicating the devices may cause temporary adverse health consequences, and 14% as class III, indicating the device is not likely to cause any adverse consequences. Only 4% were class I recalls, deemed by the FDA to have a reasonable risk of causing serious adverse health consequences or death.
During this time, cardiovascular devices were the most commonly recalled products: 532 recalls, making up 15% of all recalls during this period, while the 40 class-I recalls of cardiovascular devices represented 31% of all class-I recalls in the period. The largest number for cardiovascular devices involved automatic external defibrillators.
The next most common category is radiological devices, which accounted for 484 total recalls but only two class I recalls, followed by general hospital and personal-use devices, which accounted for 388 recalls overall, including 31 class I recalls.