Medical Device Recalls:

An Overview and Analysis 1983-88

PEMD-89-15BR: Published: Aug 30, 1989. Publicly Released: Nov 6, 1989.

Additional Materials:


Office of Public Affairs
(202) 512-4800

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.

Sep 28, 2016

Sep 15, 2016

Sep 14, 2016

Sep 12, 2016

Sep 9, 2016

Sep 6, 2016

Aug 31, 2016

Looking for more? Browse all our products here