It seems that a recent lawsuit about power morcellators in 2014 has brought up this issue again. Dr. Amy Reed underwent surgery to remove uterine fibroids using laparoscopic power morcellation, an otherwise routine hysterectomy. In this process, a tool is inserted through a small incision in order to mince an internal structure so it can be extracted more easily. However, in undergoing this process, some hidden cancerous cells were also ground up in the process and had spread throughout her abdominal area.

Power morcellators utilized the 501k process in order to get clearance back in the 90s, but it seemed that this cancer risk had not been consideredduring the approval process. This spurred Dr. Reed and her husband, Dr. Hooman Noorchashm, to take action. Together the two rallied to get this procedure and the morecellator devices banned. Overall it seems they were somewhat successful as Johnson & Johnson had withdrawn three of their devices associated with this procedure, but it remains to be seen if the actual 501k procedure itself will see any changes.

References:
http://www.medscape.com/viewarticle/828688_3
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm393689.htm