A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
Recall as defined in 21 CFR 7.3(g) is “a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.” If a firm conducts a recall to reduce a risk to health, the firm is required to submit a written report to the FDA with the information described in 21 CFR 806.10.
For additional background information about medical device recalls, see here.
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This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Subscribe to this Recall/Safety Alert feed here.
Further, FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
When necessary, the FDA will make corrections or changes to recall information previously disclosed in a past Enforcement Report for various reasons. For instance, the firm may discover that the initial recall should be expanded to include more batches or lots of the same recalled product than formerly reported.