News & Knowledge

Risk Management Guide: Medical Device and Drug Safety Recalls

FDA uses the term "recall" when a manufacturer takes a corrective or removal action to address a problem with a medical device or drug that violates FDA regulations. Recalls occur when a medical device or drug is defective, when it could be a health risk, or when it is both defective and a health risk. Usually, the device or drug manufacturer recalls a device or drug independently. Accountability for medical device and drug safety recalls A person(s) should be appointed to lead all recall-related matters. This individual should subscribe to recall alerts and regularly monitor official channels, which can help healthcare organizations stay proactive in identifying and addressing recall issues. Monitor information on FDA recalls using…

Curi’s risk mitigation resources and guidance are offered for educational and informational purposes only. This information is not medical or legal advice, does not replace independent professional judgment, does not constitute an endorsement of any kind, should not be deemed authoritative, and does not establish a standard of care in clinical settings or in courts of law. If you need legal advice, you should consult your independent/corporate counsel. We have found that using risk mitigation efforts can reduce malpractice risk; however, we do not make any guarantees that following these risk recommendations will prevent a complaint, claim, or suit from occurring, or mitigate the outcome(s) associated with any of them.