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Medical Device Recall
Removal or correction of a marketed device that violates FDA law.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
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. What the regulation says
Medical device recalls are actions taken by manufacturers, importers, or distributors to remove violative products from the market or correct them, as defined by FDA 21 CFR Part 7, Subpart C. EU MDR (Regulation (EU) 2017/745) Article 10, Section 12, requires manufacturers to take necessary corrective actions for devices that are not in conformity. ISO 13485:2016, Clause 8.5.2, outlines requirements for corrective actions, which may include recalls.What this means in practice
Most recalls are voluntary. A FDA-mandated recall is rare but possible. Recall data is publicly available.Examples
- A manufacturer initiates a Class I recall of an implantable cardiac device due to a software bug that could lead to unexpected device shutdowns, posing a risk of patient death.
- A diagnostic kit distributor issues a Class II recall because a labeling error incorrectly states the storage temperature, potentially affecting the test's accuracy.
- A cybersecurity team discovers a critical vulnerability in a networked infusion pump that could allow unauthorized access, leading the manufacturer to issue a field correction recall requiring a software patch.
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.
Frequently asked questions
The primary purpose of a medical device recall is to protect public health by removing or correcting devices that are in violation of regulatory requirements and may pose a risk to users.
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsPost-Market
Field Safety Corrective Action(FSCA)
Action taken to reduce a risk of serious deterioration in health associated with a device.
Post-Market
Medical Device Reporting (FDA)(MDR)
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Post-Market
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
Post-Market Mastery
· From this learning pathPost-Market
Periodic Safety Update Report(PSUR)
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Post-Market
Post-Market Surveillance(PMS)
Activities to monitor device safety and performance after market release.
Quality & Risk
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
Quality & Risk
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 2Regulator guidance and consensus· 3
Link health: 3 verified· last checked 2026-06-20
FDA·1European Commission·1MDCG·1
- 1FDA Recall InformationTier 2 VerifiedFDAfda.gov
- 2EUDAMED Public SiteTier 2 VerifiedEuropean Commissionec.europa.eu
- 3MDCG Vigilance GuidanceTier 2 VerifiedMDCGhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.