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What happens in a medical device recall?

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…

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What is a medical device recall?

According to the FDA, 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…

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Who recalls medical devices?

According to the FDA, usually a company (for example, the manufacturer or distributor) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, the company recalls the device (through correction or removal) and notifies…

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