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FDA Medical Device Recall Database

Search public FDA medical device recall records, including affected products, recalling firms, product codes, status, dates, root-cause descriptions, distribution, and recall actions.

Identify affected productsUnderstand the stated issueConnect safety evidenceopenFDA Medical Device Recall API

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Find recall records by device or product description, recalling firm, FDA product code, recall number, or event number.

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About the data

How to interpret FDA recall records

A recall record applies to the products, lots, serial numbers, dates, and distribution described in that record. It does not automatically apply to every device sold under the same family or brand.

Read the recall reason together with the code information, action, status, and official record. The initial scope can change as a firm or FDA gathers more information.

Recall data should be combined with current FDA safety communications, enforcement information, labeling, MAUDE reports, and the manufacturer’s field action before making a decision.

Read the official FDA dataset documentation

What is an FDA medical device recall?
It is a firm’s removal or correction of a marketed device that FDA considers to violate the laws it administers. A recall may address a defect, a health risk, or both.
Does every recall mean every unit is affected?
No. Review the product description, code or lot information, quantity, distribution, dates, and recall action to identify the affected scope.
Is a terminated recall the same as a safe product?
No. Termination describes the administrative status of the recall. It does not establish the safety or suitability of a product for a particular use.

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