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.
Medical Device Classifications
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. 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.
Class I--high risk
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. FDA may also issue its own press release or public health notice.
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.
Class II--less-serious risk
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).
Class III--low risk
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.
Medical Device Recall