Medical Device Recalls

Search Medical Device Recalls

This page gives general information about medical device recalls. For regulatory requirements and guidance, see nearby links.

• What is a recall?
• Who recalls medical devices?
• What happens in a medical device recall?
• What is a Class I recall?
• What is a Class II recall?
• What is a Class III recall?

What is a recall?

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.

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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.

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What happens in a medical device recall?

When a company recalls a medical device, it

• contacts directly the customers who received the product from them, and takes steps to reach others who need to be notified (for example, by issuing press releases or providing detailed instructions);
• supplies information to help users identify the product and take steps to minimize health consequences; and
• takes action to prevent the problem from happening again.

FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health. During a medical device recall, FDA

• works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again;
• conducts audits to make sure the recall efforts are appropriate and effective;
• makes sure the company takes necessary actions to prevent the problem from happening again.

FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, Class II, and Class III. This classification process usually takes place after the company has issued its recall.

• Class I--high risk
• Class II--less-serious risk
• Class III--low risk

FDA’s classification determines the number of checks the company has to make and the number of audits FDA will conduct to ensure the effectiveness of the recall action. It is intended to make sure that the company has followed through on its decision to implement the recall action

Note: The responsibility for an adequate recall belongs to the manufacturer. The decision and timing of FDA’s recall classification does not change or delay the company’s obligation to take appropriate action.

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What is a Class I recall?

A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death.

In a Class I recall, the company:

• notifies their customers (i.e. distributors or vendors), and directs them to notify the intended recipients of the device (i.e. other vendors, hospitals, nursing homes, outpatient treatment facilities, doctors, or individual patients). The notification usually contains the name of the device being recalled, identifying lot or serial numbers, the reason for the recall, and instructions about how to correct, avoid, or minimize the problem. It should also provide a telephone number for questions related to the recall.

• issues a press release to notify the public, if appropriate to minimize health consequences.

FDA may also issue its own press release or public health notice.

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What is a Class II Recall?

A Class II recall usually represents a less-serious risk than a Class I recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

In a Class II recall, the company notifies their customers (i.e. distributors or vendors) and sometimes asks them to notify the intended recipients of the device. FDA generally does not issue a press release or expect the company to issue a press release for Class II recalls, unless there is a specific need to do so (for example, if the device could affect the health of a large number of people, if patients need more information, or if the recalling company could not reach every intended recipient).

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What is a Class III Recall?

A Class III recall represents a less-serious risk than a Class II recall. In a Class III recall, there is little chance that using or being exposed to the device will cause health problems. However, because the product violates FDA law, there is still a need to take an action to address the problem.

In a Class III recall, the company notifies their customers (i.e. distributors or vendors). FDA would not issue a press release, and it would not expect the company to issue a press release.

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