--- title: "FDA Recall Classifications I, II, III… | MedTech Terms" description: "FDA's risk-based grading of recalls based on potential for harm. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. FDA Recall Classifications I, II, III [All terms](/terms) Post-Market [Quality System](/ecosystems/quality-system)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets) # FDA Recall Classifications I, II, III FDA's risk-based grading of recalls based on potential for harm. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Class I recalls involve a reasonable probability of serious adverse health consequences or death; Class II involves temporary or medically reversible harm; Class III is unlikely to cause adverse health consequences. What the regulation says The FDA categorizes medical device recalls into three classes, I, II, and III, based on the degree of health hazard. This classification, outlined in 21 CFR Part 7, Subpart C, dictates the urgency and scope of action required from the recalling firm and the FDA. The FDA’s Regulatory Procedures Manual ( [RPM](/terms/remote-patient-monitoring)) Chapter 7 provides further guidance on recall policies and procedures. ## What this means in practice Classification determines public notification expectations and effectiveness-check rigor. The Recall Strategy and [Health Hazard Evaluation](/terms/health-hazard-eval) drive the classification decision. ## Examples - A manufacturer discovers a software bug in an implanted cardiac device that could cause it to stop functioning, leading to patient death. This would likely result in a Class I recall. - A sterile surgical instrument is found to have minor, non-critical packaging defects that do not compromise sterility but might lead to user confusion. This could lead to a Class III recall. - A diagnostic test kit produces slightly inaccurate results that could lead to a temporary misdiagnosis, but without permanent patient harm. This condition often results in a Class II recall. Common pitfalls - • Misinterpreting a Class II recall as less critical, potentially delaying appropriate corrective actions. - • Failing to conduct a thorough Health Hazard Evaluation, which can lead to an incorrect recall classification. - • Underestimating the resources required for a Class I recall, impacting the speed and effectiveness of product removal. - • Not understanding that even Class III recalls require proper documentation and communication with the FDA. - • Assuming that a recall classification is permanent and cannot be re-evaluated if new information arises. ## Frequently asked questions What is the primary factor in determining recall classification? The primary factor is the [Health Hazard Evaluation](/terms/health-hazard-eval) (HHE), which assesses the probability of adverse health consequences and their severity. Does the FDA issue recall classifications, or does the manufacturer? What are the implications of a Class I recall for a manufacturer? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ Medical Device Recall ](/terms/recall) ## 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 Recall Removal or correction of a marketed device that violates FDA law. ](/terms/recall) ### 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)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Quality System](/ecosystems/quality-system) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 FDA Recall Procedures Verified FDA · fda.gov ](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions) 2. [2 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) 3. [3 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 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-classifications) Learn in 60 seconds Card Lesson Quiz FDA's risk-based grading of recalls based on potential for harm. - · Classification determines public notification expectations and effectiveness-check rigor. - · The Recall Strategy and Health Hazard Evaluation drive the classification decision. Remember this Watch out: Misinterpreting a Class II recall as less critical, potentially delaying appropriate corrective actions. Related terms - [Medical Device Recall ](/terms/recall) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) You may also need Auto-suggested from Post-Market and shared keywords. - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [Software Safety Classification ](/terms/software-safety-class) - [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [Serious Adverse Event(SAE) ](/terms/sae) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) [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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