About this reference

Every medical device recall published by the U.S. Food & Drug Administration is made public through the openFDA project. This site is a fast, searchable mirror of that dataset — every recall, every class, every recalling firm.

What's a Class I recall?

FDA classifies recalls by severity of the health risk:

• Class I — reasonable probability that use of or exposure to the device will cause serious adverse health consequences or death.
• Class II — use may cause temporary or medically reversible adverse health consequences; probability of serious consequences is remote.
• Class III — use is not likely to cause adverse health consequences.

Recalls are graded by the FDA's Division of Enforcement; the classification is a health-hazard assessment, not a legal finding.

Data source

All records sourced from openFDA's device recall endpoint via its published JSON bulk export. Refreshed weekly. The date each record was most recently updated by FDA is shown on the individual recall page.

Not legal or medical advice

If you believe you were injured by a recalled device, contact your healthcare provider and consider consulting a licensed attorney. If you own a device currently under recall, follow the recalling firm's instructions in the recall notice or contact the firm directly.