Medical Device Recalls

An FDA medical device recall is an action taken to address a problem with a medical device that violates FDA law. A recall may be initiated by the manufacturer, importer, or FDA itself. Recalls address issues such as software errors, manufacturing defects, labeling problems, sterility failures, and component malfunctions. Medical devices range from simple bandages to complex implantable devices like pacemakers and artificial joints.

Class I is the most serious — there is a reasonable probability that use of the device will cause serious adverse health consequences or death. Class II means the device may cause temporary or medically reversible adverse health effects. Class III is the least serious — unlikely to cause adverse health consequences.

Contact your healthcare provider immediately, especially for implanted devices. Do not remove or modify any implanted device yourself. Follow the recall instructions for returning or replacing the device. Your doctor can determine whether immediate action is needed or if monitoring is sufficient. Report any adverse events to the FDA through MedWatch.

All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. We maintain 38,428 device safety records from 1930 to 2026.