On June 14, 2011, the GAO released a report entitled "Medical Devices: FDA Should Enhance Its Oversight of Recalls." The report identifies: (1) the numbers and characteristics of medical device recalls and the FDA’s use of this information to aid its oversight, and (2) the extent to which the recall process ensures the effective implementation and termination of the highest-risk recalls. GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA's documentation for a sample of 53 (40%) of class I recalls initiated during this period. From 2005 through 2009, the GAO found that firms initiated 3,510 medical device recalls, or an average of 700 per year. FDA classified the vast majority--nearly 83%--as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote. Just over 40% of the recalls involved cardiovascular, radiological, or orthopedic devices. The GAO found that the FDA has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls and therefore is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices. The GAO also found that gaps in the medical device recall process limited firms' and FDA's abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices and that FDA's procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were effective. FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices. The GAO report indicates that FDA's decisions to terminate completed recalls--that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls--were frequently not made within its prescribed time frames. Finally, FDA did not document its justification for terminating recalls. The report concluded that if unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market. To enhance FDA’s oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the GAO recommended that FDA take the following four actions: (i) creation of a program to routinely and systematically assess medical device recall information, which should be designed, at a minimum, to identify trends in the numbers and types of recalls, the devices most frequently being recalled, and underlying causes of recalls; (ii) clarification of procedures for conducting medical device recall audit checks to improve the ability of investigators to perform these checks in a consistent manner; (iii) development of explicit criteria for assessing whether recalling firms have performed an effective correction or removal action; and (iv) documentation of the FDA’s basis for terminating individual recalls. HHS reported that FDA plans to convene a working group to both evaluate improvements to the recall process and to develop strategies to implement the GAO's recommendations.