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 a risk to health.
A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
Examples of the types of actions that may be considered recalls:
- Inspecting the device for problems
- Repairing the device
- Adjusting settings on the device
- Re-labeling the device
- Destroying device
- Notifying patients of a problem
- Monitoring patients for health issues
Sometimes a company may have concerns about a group of products, but it cannot predict which individual devices will be affected. To be on the safe side, the company may recall an entire lot, model, or product line.
A recall is either a correction or a removal depending on where the action takes place.
- Correction - Addresses a problem with a medical device in the place where it is used or sold.
- Removal - Addresses a problem with a medical device by removing it from where it is used or sold.
Who recalls medical devices?
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.