Manufacturers must report to FDA within 10 working days corrections or removals initiated to reduce health risk or remedy violations. Some actions are exempt (e.g., normal service, market withdrawal not for safety/violation). A correction is the repair, modification, adjustment, relabeling, destruction or inspection of a device without physically removing it from where it is used; a removal is moving it to another location for those actions. Reports go to the FDA district office and must include specific information listed in 21 CFR 806.10. Actions that are not reportable must still be recorded, with the reason, under 806.20.

Why it matters

806 reporting is separate from recall classification; the two systems intersect but have distinct triggers and timelines.

Common pitfalls

•A common pitfall is misunderstanding the reporting criteria, leading to underreporting or overreporting of events to the FDA.
•Manufacturers often incorrectly assume that all product withdrawals constitute a reportable removal under 21 CFR Part 806.
•Failing to initiate appropriate corrective and preventive actions (CAPA) following a reported correction or removal can lead to repeat issues and regulatory scrutiny.
•Not adequately documenting the decision-making process for whether an action is a correction or removal, or an exempt activity, can result in compliance deficiencies.
•Confusing the reporting requirements of 21 CFR Part 806 with Medical Device Reporting (MDR) under 21 CFR Part 803 can lead to incorrect submissions and timelines.

Sources

21 CFR 806 · eCFR
FDA Recalls - Medical Devices · FDA
EUDAMED Public Site · European Commission

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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

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.