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:
- Recalls the device (through correction or removal)
- Notifies the FDA
The FDA can legally require a company to recall a device. Recalls can be disruptive, and well-managed recalls are not accidental – they are the result of extensive preparation well ahead of time. Recall teams with the right abilities and experience need to be assembled. Adequate risk management practices have to be implemented.
