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U.S. Department of Health and Human Services

Medical Device Recalls

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This database contains Medical Device Recalls classified since November 1, 2002. Beginning January 3, 2017, the database includes correction or removal actions initiated by a firm prior to recall classification. The status of the action is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. Recalls for medical devices regulated by the Center for Biologics Evaluation and Research may not be included in this database. CBER recall information is available here. Learn More...

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