The Recall Impact - Pt. 1 The Increasing Danger
Medical Device Industry

The Recall Impact Part 1 – The Increasing Danger

By February 22, 2016 No Comments

The amount of defective medical device recalls almost doubled from 2003 to 2012, says a 2014 report from the Food and Drug Administration (a nearly 100% increase during those years). Although these numbers are staggering and mean that the medical device industry is facing a dangerous level of liability, as well as lost profits, there has still been a resistance to change.


Since the FDA has increased its efforts to improve the quality and safety of medical devices there has been a larger number of reported recalls, which has provided a great benefit to public health. The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. Although the recalls are beneficial to the public, it is incredibly alarming that a sharp increase in Class 1 device recalls was seen. These are cases in which use of the defective product could mean a possibility of death (1).

Recalls usually occur for one of two causes:

  • A voluntary recall, which occurs when the company manufacturing the device finds a critical problem with the product
  • An involuntary recall which is mandated by a regulative agency

EngiLifeSciences believes the only way to ensure compliance is through an integrated, end-to-end approach to quality. Rather than trying to establish compliance within each subsystem, it is more effective and sustainable to horizontally incorporate requirements and establish relationships between subsystems, departments and business units.

Please contact us today for more information on how we can assist you with this process.


[1] “Medical Device Recall Report – FY2003 to FY2013.” Food and Drug Administration. Web. April 2015.
Additional Source:
Medical Tracking Solutions, MTS Blog: The Big, Bad, and Ugly Costs of Medical Device Recalls

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