Medical Device Recalls Increase Dramatically in 2012

A disturbing trend is developing involving medical devices. In the first two quarters of 2012, the Food and Drug Administration (FDA) issued 519 recalls involving over 200 million medical device units.

The FDA issued 242 medical device recalls in the second quarter of 2012. Although this is fewer than the 277 medical device recalls issued in the first quarter of 2012, the number of units recalled during the second quarter of this year affected over 123 million units, an increase of 4 percent over the second quarter of 2011. 142 different companies were involved in these recalls during the second quarter alone.

The good news, however, is that of the 123.5 million units recalled in the second quarter, fewer than 7 percent were Class I recalls. Class I recalls involve devices whose continued use can cause serious bodily injury or death.

As a side note, 12 million units of prescription drugs were also recalled in the second quarter via 69 pharmaceutical recalls issued by the FDA.

What is a consumer to do? First and foremost, be an active participant in your own medical care. Make informed choices about medical devices. Question your doctor about the need for the medical device and whether any alternatives exist. Do your own research about the efficiency and safety record of the medical device that is recommended to you or that you are already using.

Becker Law Office is experienced in handling injuries caused by a defective medical device or prescription drug. Contact Becker Law Office if you have any questions about defective medical devices or prescription drugs.