Medical Device Recalls

Pursuant to a congressional request, GAO provided information on 1,635 medical devices recalled between fiscal years 1983 and 1988.

GAO found that: (1) the Food and Drug Administration (FDA) classified 1,026 of the recalled devices as medium-serious, 561 as least-serious, and 48 as most-serious in terms of potential adverse health consequences; (2) the annual number of recalls fluctuated, with annual totals not exceeding 200 prior to 1985, but consistently near or above 300 after 1985; (3) although recalled devices represented all 19 medical specialty categories, 80 percent of recalled devices fell into 8 categories, and the top 2 categories, cardiovascular and anesthesiology devices, accounted for 25 percent of recalls; (4) even recalls categorized as least-serious could pose serious health consequences; (5) recalled devices included such high-risk, life-supporting devices as replacement heart valves, such medium-risk devices as tanning booths, and such low-risk devices as dental irrigation syringes; (6) design and production problems accounted for almost 75 percent of recalls; (7) 74 percent of all most-serious recalls involved medium-risk devices; (8) only 22 percent of recalls had the required medical device reporting regulation report in their files; (9) about 5 percent of recalled products had received FDA premarketing approval; and (10) premarketing-approved devices were more likely to be classified under the most-serious classification than under the other two categories.