Medical Device Recall Firms

A medical device recall is an action taken to address a product that violates FDA law. This includes removing or correcting devices that are defective, could cause health problems, or may have been manufactured in violation of FDA regulations. Recalls can involve removing the product from market, correcting it, or simply notifying users of a potential issue (called a "correction" rather than a "removal"). The FDA classifies recalls into three classes based on severity, from Class I (most serious) to Class III (least serious).

Do not panic, an implanted device recall does not automatically mean the device must be removed. Many implant recalls involve software updates, monitoring protocols, or labeling changes rather than explantation. Contact your physician immediately to discuss whether your specific device (identified by its serial number or model number) is affected and what the recommended action is. In most cases for Class II or III recalls, the risk of surgery to remove the device outweighs the risk posed by the recall issue. Your doctor will follow FDA and manufacturer guidance for your specific situation.

Medical device recalls are typically self-initiated, the manufacturer discovers a quality issue through internal testing, complaint analysis, or adverse event reports and notifies the FDA. Once a recall is underway, the company must notify all direct accounts (distributors, hospitals, clinics) through recall communications. The FDA oversees the recall strategy and effectiveness checks. Manufacturers must submit periodic status reports and, for Class I recalls, verify that they have reached all affected users. The FDA publishes all recall information in its enforcement database.

Use the search bar above to look up any company by name. You can also browse the full recall database and filter by manufacturer name using the keyword search. For specific device recalls by product name or model number, use the Browse All Recalls page. The FDA also maintains the MAUDE (Manufacturer and User Facility Device Experience) database at FDA.gov for more detailed adverse event reports submitted about specific devices.