--- title: "Medical Device Recall, Definition | MedTech Terms" description: "Removal or correction of a marketed device that violates FDA law. Plain-English Post-Market definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/recall#term", "name": "Medical Device Recall", "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Medical Device Recall [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets) # Medical Device Recall Removal or correction of a marketed device that violates FDA law. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 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. 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](/terms/mdr-reporting) (Regulation (EU) 2017/745) Article 10, Section 12, requires manufacturers to take necessary corrective actions for devices that are not in conformity. [ISO 13485](/terms/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 What is the primary purpose of a medical device recall? 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. How are medical device recalls classified? Who is responsible for initiating a medical device recall? ## Cross-references ### Contains Sub-elements or required artefacts of this term. - [ FDA Recall Classifications I, II, III ](/terms/recall-classifications) ### See also Closely related context worth reading. - [ Field Safety Corrective Action(FSCA) ](/terms/fsca) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca)[ Post-Market Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance) ### Post-Market Mastery · From this learning path [ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur?from=post-market-mastery)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance?from=post-market-mastery)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=post-market-mastery)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa?from=post-market-mastery) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Post-Market Mastery](/paths/post-market-mastery)Lesson 5 of 9 Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Mentioned in recent activity 1 entry Recalls (1) [See Luer Cap Set, MPC-130, set, administration, intravascular ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1774-2026) Class II · 2026-02-17 ## Latest in MedTech [View all](/latest?term=recall) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - Recall 2026-02-17 [See Luer Cap Set, MPC-130, set, administration, intravascular ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1774-2026) Class II · Molded Products Inc ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 MDCG· 1 1. [1 FDA Recall Information Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) 2. [2 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 3. [3 MDCG Vigilance Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=recall) Learn in 60 seconds Card Lesson Quiz Removal or correction of a marketed device that violates FDA law. - · Most recalls are voluntary. - · A FDA-mandated recall is rare but possible. - · Recall data is publicly available. Remember this Watch out: A common misconception is that all recalls are FDA-mandated, whereas the vast majority are initiated voluntarily by the firm. Related terms - [Field Safety Corrective Action(FSCA) ](/terms/fsca) - [Medical Device Vigilance ](/terms/vigilance) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) You may also need Auto-suggested from Post-Market and shared keywords. - [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction) - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Customer Notification Letter ](/terms/customer-notification) - [Field Action vs Recall ](/terms/field-action-vs-recall) - [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval) - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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