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 the FDA.

Legally, the FDA can require a company to recall a device. This forced recall can occur if a company refuses to recall a device that is associated with significant health problems or death. In practice, however, the FDA has rarely needed to require a medical device recall.