Welcome to the BI 108 Organ Replacement web site on major recalls of such medical devices. This site contains information describing how the United States Food and Drug Administration (FDA) regulates recalls of defective medical devices. Specific cases are described with information regarding failure of the device, actions taken by the company, and what one needs to know if one received such a device. We will touch on how some biomedical companies produced and distributed flawed products that were approved globally or domestically.
For more information on additional recalls see the FDA web site: Medical Device Recalls.
Disclaimer: The content of this web page does not reflect the opinion of Brown University or any of its affiliates. Please see company or FDA web sites for additional information.