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Glossary Term
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Voluntary Recall

Definition

A voluntary recall is a proactive action taken by a manufacturer or distributor to remove a product from the market due to potential safety issues, defects, or non-compliance with regulatory standards. Unlike a mandatory recall initiated by a regulatory body, such as the FDA, a voluntary recall is initiated by the company itself. This process involves notifying customers, healthcare providers, or patients about the potential risks associated with the product and providing instructions on how to return, dispose of, or correct the issue with the product. Voluntary recalls help companies manage safety concerns, protect public health, and maintain regulatory compliance.

Relevance to the MedTech Industry

Voluntary recalls play into a company’s commitment to patient safety and product quality. When a defect or safety concern is identified with a medical device or product, initiating a voluntary recall allows the company to address the issue quickly and responsibly, potentially avoiding larger public health crises or regulatory action. Recalls are particularly critical in the medical device industry, where product failures or safety concerns can directly impact patient health and the reputation of the manufacturer. Companies that handle recalls efficiently and transparently can mitigate risks, maintain customer trust, and comply with regulatory requirements.

Additional Information & Related Terms

Related Terms

  • FDA Recall: A recall initiated by the FDA when a product is found to pose a risk to patient safety, which may be triggered after a voluntary recall or following the FDA's investigation.

  • Corrective and Preventive Action (CAPA): A process used to address the root cause of a product defect or safety issue and to prevent future occurrences, often part of a company’s strategy during a voluntary recall.

  • Product Recall Notice: A formal notification issued by the manufacturer or regulatory body informing the public or specific stakeholders about the recall of a product.

  • Risk Management: The process of identifying, assessing, and mitigating risks associated with a product, often involved in determining the need for and scope of a recall.

  • Adverse Event: An unintended negative outcome that can trigger a recall, particularly if the event poses a risk to patient safety.

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