Post-Market
Medical Device Recall
In one line
Removal or correction of a marketed device that violates FDA law.
Definition
Per 21 CFR Part 7, a recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action. Classes I–III reflect risk of serious health consequences.
Most device recalls are voluntary actions initiated by the firm, but FDA has authority to order recalls under 21 CFR Part 810 when there is a reasonable probability of serious harm. FDA classifies each recall, oversees the firm's strategy and checks effectiveness, and publishes recalls in its database. Firms must also report corrections and removals under 21 CFR Part 806. In 2024 FDA began an early alert communication pilot for some high-risk recalls.
Why it matters
Most recalls are voluntary. A FDA-mandated recall is rare but possible. Recall data is publicly available.
Common pitfalls
- •A common misconception is that all recalls are FDA-mandated, whereas the vast majority are initiated voluntarily by the firm.
- •Failing to promptly report a recall to the relevant regulatory authorities can lead to severe penalties and regulatory action.
- •Not having a well-defined recall plan in place can result in chaotic and ineffective recall execution, increasing patient risk.
- •Assuming that a recall only involves removing physical products, neglecting necessary software updates or field corrections, is a mistake.
- •Underestimating the importance of clear and consistent communication with affected parties during a recall can damage a company's reputation and trust.
Sources
- FDA Recall Information · FDA
- EUDAMED Public Site · European Commission
- MDCG Vigilance Guidance · MDCG