In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things:
- Recalls the device (through correction or removal)
- Notifies FDA.
Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall.