What happens in a medical device recall?

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According to the FDA, when a company recalls a medical device, it contacts and notifies customers directly, supplies information to help patients or users identify the recalled product to minimize consequences, takes action to prevent the problem from reoccurring.

The FDA oversees each recall to make sure that the company’s actions are adequate to protect the public health. During a medical device recall, the FDA works with the recalling company to obtain information about the product, the problem, the recall strategy, and steps to prevent the problem from happening again; the FDA audits to confirm that recall efforts are appropriate and effective; the FDA makes sure the company takes necessary actions to prevent the problem from occurring again.