# Class I Recall

> The most serious FDA recall classification, indicating a reasonable probability that the product will cause serious adverse health consequences or death.

**Category:** Regulatory
**Canonical URL:** https://drugsmonitor.com/glossary/class-i-recall
**Last updated:** 2026-06-11

Class I recalls represent the highest level of FDA enforcement action. Examples include medications contaminated with toxic substances, devices that can cause fatal malfunctions, or products with dangerous labeling errors.

When a Class I recall is issued, the manufacturer must notify all consignees and conduct a recall effectiveness check. The FDA monitors the recall and can seize products or seek court orders if the recall is not effective.

A Class I recall is strong evidence in product liability litigation that the product was defective. Patients who were injured by a recalled product should preserve the product and documentation and consult with counsel promptly.

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*Glossary entry from DrugsMonitor.com.*