A recall is the process of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Medical device recalls are initiated one of two ways: In most cases, a manufacturer, distributor, or otherwise responsible party voluntarily recalls a medical device without any direction from the FDA. When a company takes notice that one of its products violates FDA law, it typically acts in two ways:
With its legal authority, the FDA may order a company to involuntarily recall a device. This may occur if a company refuses to recall a device that is allegedly associated with significant health problems or fatalities. However, in the last several decades, the FDA has rarely needed to require any company to recall a medical device.
Upon receiving notification of a company’s correction or removal action, the FDA:
A recall may be classified as follows:
Once it classifies a recall, the FDA monitors it to ensure that the violating company’s recall strategy has worked effectively as proposed. The FDA only terminates a recall after it is assured that a product is no longer a health hazard and in violation of federal law.
When a company initiates a correction or removal action, the FDA posts notice of the action and any other relevant information in the Medical Device Recall Database. The FDA updates this database upon classifying and terminating the recall.
The FDA regularly posts private press releases and other public notices related to product recalls, market withdrawals, and safety alerts that may potentially present significant risks to consumers or users. After a recall has been classified, the FDA publishes a further notice in its Enforcement Report released weekly.
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