FDA Recall Classes (I, II, III)
FDA recall classes rank the health hazard of a recall: Class I for situations with a reasonable probability of serious harm or death, Class II for temporary or reversible harm, and Class III where adverse consequences are unlikely.
How does the FDA classify recalls?
When a firm initiates a recall of a marketed device, the FDA evaluates the health hazard and assigns a classification, which may later appear in the recall database. Under the FDA's recall definitions, Class I means a reasonable probability that use or exposure will cause serious adverse health consequences or death; Class II covers temporary or medically reversible harm, or a remote probability of serious harm; Class III means adverse health consequences are not likely.
Are recalls ordered by the FDA?
Most device recalls are initiated voluntarily by a firm. The FDA can request a recall and has mandatory device-recall authority under section 518(e) of the FD&C Act when the statutory conditions are met. After initiation, the agency may classify the recall, review the strategy, evaluate effectiveness and terminate the recall. "Voluntary" describes who initiated the action; it does not reduce the need for a timely, documented response to a health risk or violation.
What is the difference between a recall and a market withdrawal?
A recall is a removal or correction of a marketed product that the FDA considers violative and against which it would initiate legal action. A market withdrawal concerns either no violation or a minor violation that would not be subject to FDA legal action. A stock recovery concerns product that has not been marketed or left the firm's direct control. Reporting under 21 CFR Part 806 is a separate assessment: a correction or removal is reportable when it was initiated to reduce a risk to health or remedy a violation that may present a risk to health.
Do recall classes match device classes?
No. Device classification (I to III) identifies the regulatory controls for a device type; recall classification ranks the health hazard of a specific field problem. A Class I device can therefore be involved in a Class I recall. Companies operating in the United States also assess reporting and field-action duties in every other market where affected units were supplied.
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