A recall of a product is taken by the manufacturer or the government when there is a health or safety issue with the product. In other words this product may harm the consumer.
Sometimes the manufacturer will recall the product on its own or the FDA will issue an order to recall the product. Companies that design, manufacture or relabel or import medical devices are regulated by the FDA.
The FDA will either:
(1) clear the device under 510k or
(2) approve the device after reviewing premarket approval.
Under the 510k clearance, the manufacturer must only show that it is substantially similar to a device that is already on the market for the same use. To receive premarket approval the manufacturer must show the products safety and effectiveness.