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.
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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.
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Identify affected products
Review product descriptions, lot or serial information, quantities, and distribution patterns.
Understand the stated issue
Read the firm’s reason for recall, root-cause description, and corrective action.
Connect safety evidence
Continue from a product code into MAUDE reports, classifications, clearances, approvals, and GUDID records.
Search FDA device recalls
Find recall records by device or product description, recalling firm, FDA product code, recall number, or event number.
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Important interpretation note
OpenFDA states that its recall dataset should not be used alone to issue public alerts or track a recall lifecycle. Verify current status and scope with the official FDA record and manufacturer communication.
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.
Frequently asked questions
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.
How often is the recall data updated?
FDA states that the openFDA Medical Device Recall endpoint is updated weekly. Always verify time-sensitive details with the official FDA record.