Pharmaceutical and medical device recalls

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Statista dossier about recalls of pharma products and medical devices in the United States

This dossier presents information regarding recalls of pharmaceutical products and medical devices in the United States. Data on recall numbers and causes for recalls are included, as well as information on Food and Drug Administration (FDA) activity in issuing warnings and enforcing laws and regulations regarding the production and sale of pharmaceutical products and medical devices.

Table of contents

  • 1. Overview
    • Share of pharmaceutical recalls in the U.S. by cause 2018

    • Number of units per pharmaceutical product recall in the U.S. 2014-2018

    • Pharmaceutical product recall costs 2012, by cost type

    • Annual medical device recalls in the U.S. 2013-2017

    • Causes for medical device recalls in the U.S. 2010-2015

  • 2. Pharmaceutical product recalls
    • List of FDA approved drugs later pulled from market in the U.S. until 2014

    • Number of all FDA drug product recall enforcement reports issued 2012-2017

    • Number of FDA issued drug recall enforcement reports 2012-2017 by type

  • 3. Digression: pharmaceutical violations
    • Pharmaceutical industry violations in the U.S. 1991-2017, by violation type

    • Pharmaceutical industry financial penalties in the U.S. 1991-2017, by violation type

    • Pharmaceutical industry financial penalties - United States 1991-2017

  • 4. Medical device recalls
    • Distribution of major causes for medical device recalls in U.S. 2018

    • Quarterly number of medical device recalls in U.S. 2015-2018

    • FDA medical devices recalls by class FY 2017

    • Number of medical device recalls due to software issues in the U.S. 2010-2017

  • 5. Medical devices- inspections and warnings
    • FDA foreign and domestic medical device establishment inspections 2009-2017

    • FDA medical device establishment inspections worldwide 2009-2017

    • FDA warning letters over medical devices 2009-2017

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