Glossary Term
Recall
Definition
A recall is a process initiated by a manufacturer, distributor, or regulatory body to remove or correct a medical device that is found to be defective, unsafe, or non-compliant with regulatory standards. Recalls are typically issued when a device poses a risk to patient safety or does not meet the standards set by regulatory agencies such as the FDA or EMA. Recalls can be voluntary or mandated by regulatory authorities and may involve removing products from the market, correcting defects, or providing instructions for safe use. The goal of a recall is to prevent harm to patients, mitigate potential risks, and ensure compliance with applicable regulations.
Relevance to the MedTech Industry
Recalls are issued as a way to protect patient safety and public health by removing, correcting, or managing products that could pose a risk due to defects, contamination, or non-compliance with regulatory requirements. Recalls serve as a mechanism for addressing post-market safety issues and ensuring that medical devices meet the required safety and performance standards throughout their lifecycle.
Additional Information & Related Terms
Key Aspects of a Medical Device Recall
Identification of the Issue:
The first step in a recall process is identifying the defect, non-compliance, or safety issue that poses a risk to patients. This could come from adverse event reports, complaints, clinical data, or inspections.
Notification to Affected Parties:
Once the issue is identified, the manufacturer or regulatory body must notify the affected parties, including healthcare providers, patients, distributors, and retailers. Notifications often include details about the device, the nature of the issue, and instructions on what to do next.
Correction or Removal:
Depending on the nature of the recall, the product may be removed from the market, corrected, or replaced. In some cases, patients may be asked to return the product, while in others, manufacturers may implement corrective actions to fix defects.
Regulatory Reporting:
Manufacturers are required to report recalls to regulatory agencies like the FDA. These reports include details about the issue, the actions taken, and the impact on patients or users. Regulatory bodies may also track the recall to ensure proper resolution.
Follow-up and Monitoring:
After a recall, follow-up is essential to confirm that corrective actions have been successfully implemented and that the recalled product is no longer in circulation. Manufacturers may also continue to monitor the device in the field to assess the effectiveness of the recall.
Related Terms
FDA Recall: A recall initiated by the FDA or a manufacturer to address products that may pose a risk to patient safety or do not meet regulatory standards.
Medical Device Reporting (MDR): A system used by manufacturers, healthcare providers, and patients to report adverse events, which may trigger a recall.
Corrective and Preventive Action (CAPA): A process used to identify the root cause of a defect or non-compliance, often initiated following a recall.
Product Recall Notice: A formal notification issued to customers, healthcare providers, and regulatory bodies to inform them about a recall.
Market Withdrawal: A voluntary removal of a product from the market that does not necessarily pose a risk to patients but requires corrective actions, often related to labeling issues or manufacturing errors.