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An exploratory analysis of U.S. FDA Class I medical device recalls: 2014–2018

Abstract Medical device manufacturing and distribution is globalised; consequently, medical device failures pose serious but preventable global public health hazard. Moreover, a clear understanding of recalls will help firms improve their operations. This study examines 871 U.S. FDA Class I (i.e. most serious) medical device recalls, highlights the shortcomings of the recall reporting system and proposes recommendations for improvement. Top three recall reasons are: “packaging” (47.4%), “component” issues (14%) and “design” (13.3%). About 40% of recall events have mischaracterised or ambiguous “FDA Determined Cause”. Ninety-four firms are related to the recalls and the majority (78%) of the recall events emanate from U.S.-headquartered firms. Thirty-four firms (36%) have been acquired or are a subsidiary of another. Results also yield recommendations for improvement. The cause classification scheme needs revision and there might be a case for more than one classification scheme. Specifically, the “device design” cause designation is conflated with “component quality” issues. “Other”, “unknown” and “under investigation” designations should be replaced with real cause determinations. The effectiveness of “Good Manufacturing Practices (GMP)” and the impact of mergers and acquisitions (M&A) on device quality should be examined. Devising a “recall severity measure” and improving and standardising the recalls database are other important issues. Results and recommendations may hold lessons for other jurisdictions as well.