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Pharmaceutical and medical device recalls in the U.S.

Statistics report about recalls of pharma products and medical devices in the United States

This report 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.

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Table of contents

Overview

5
  • Premium Statistic Share of pharmaceutical recalls in the U.S. by cause 2019
  • Basic Statistic Number of units per pharmaceutical product recall in the U.S. 2014-2019
  • Basic Statistic Pharmaceutical product recall costs 2012, by cost type
  • Premium Statistic Annual medical device recalls in the U.S. 2013-2017
  • Premium Statistic Causes for medical device recalls in the U.S. 2010-2015

Pharmaceutical product recalls

3
  • Premium Statistic List of FDA approved drugs later pulled from market in the U.S. until 2014
  • Premium Statistic Number of all FDA drug product recall enforcement reports issued 2012-2024
  • Basic Statistic Number of FDA issued drug recall enforcement reports 2012-2017 by type

Digression: pharmaceutical violations

3
  • Premium Statistic Pharmaceutical industry violations in the U.S. 1991-2017, by violation type
  • Premium Statistic Pharmaceutical industry financial penalties in the U.S. 1991-2017, by violation type
  • Basic Statistic Pharmaceutical industry financial penalties - United States 1991-2017

Medical device recalls

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  • Premium Statistic Distribution of major causes for medical device recalls in U.S. 2019
  • Basic Statistic Quarterly number of medical device recalls in U.S. 2015-2019
  • Basic Statistic FDA medical devices recalls by class FY 2017
  • Premium Statistic Number of medical device recalls due to software issues in the U.S. 2010-2018

Medical devices- inspections and warnings

3
  • Premium Statistic FDA foreign and domestic medical device establishment inspections 2009-2024
  • Basic Statistic FDA medical device establishment inspections worldwide 2009-2024
  • Basic Statistic FDA warning letters over medical devices 2009-2017
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