2026 FDA Class I Recall Analysis: The Year's Most Serious Drug & Device Recalls

About this data

The People's Justice Research Team compiled this snapshot directly from the FDA's public openFDA Enforcement databases. It counts every recall classified by the FDA as Class I — its most serious tier — with a report date in 2026. Class I means the FDA has determined there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

What the data shows

In 2026 to date, the FDA announced 147 Class I recalls — 135 involving medical devices and 12 involving drugs. The recalling firm with the most Class I recalls this year was Medline Industries, LP (50). The table below lists the firms with the most Class I recalls in 2026.

Important context

A recall is a corrective action by a manufacturer, often voluntary, and the presence of a recall does not establish that any specific person was injured or that any legal claim exists. People's Justice is not a law firm and does not provide legal or medical advice. Do not stop taking any prescribed medication without first speaking to your doctor. If you believe you were harmed by a recalled product, a licensed attorney can review your individual situation.

Methodology

Source: openFDA Device Enforcement and Drug Enforcement APIs (api.fda.gov), the FDA's official public enforcement-report data. Query: classification = "Class I" with a 2026 report date. Counts reflect data available as of the last update date shown and may change as the FDA posts additional reports. Figures are reproduced as published by the FDA without modification.