The United States Food and Drug Administration (FDA) or a device manufacturer may issue a recall or safety alert if a problem occurs with a device.
Substantial harm refers to a serious adverse health consequence or death.
(1) potential harm
(2) violation level
major problem in manufacturing or distribution
Class I Recall
substantial injury remote; may cause temporary or medically reversible adverse health effect
Class II Recall
unlikely to cause adverse health effect
Class III Recall
unlikely to cause a problem; resolved once removed from the market
minor product violation, may include tampering
A medical device safety alert is issued when there is an unreasonable risk of substantial harm. It may be issued in conjunction with a device recall.
To read more or access our algorithms and calculators, please log in or register.