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.
Parameters:
(1) potential harm
(2) violation level
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Harm
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Violation Level
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Term
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substantial
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major problem in manufacturing or distribution
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Class I Recall
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substantial injury remote; may cause temporary or medically reversible adverse health effect
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major problem in manufacturing or distribution
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Class II Recall
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unlikely to cause adverse health effect
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major problem in manufacturing or distribution
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Class III Recall
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unlikely to cause a problem; resolved once removed from the market
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minor product violation, may include tampering
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Market Recall
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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.
