Medical Device Recalls

Packaging, Labeling and Software - The Human Machine Interface / HMI

The majority of medical device recalls are due to labeling or software - HMI issues. TVT can help keep you from becoming a statistic.    

Q1 2018

  • Medical device recalls increased 126% this past quarter, more than double last quarter and the largest quarter since at least 2005.

  • 22.7% of recalls were for software, making it the top cause for the eighth consecutive quarter.

  • The average class I units recalled in Q1 2018 alone was 186,580,917. The average number of units recalled the entire year in 2017 was a fraction of this at 511,017.

Q4 2017

  • Medical device recalls declined 9%, the lowest quarter since Q4 2011,

  • However, 25.7% of recalls were for software, making it the top cause for the seventh consecutive quarter. The 2nd reason for recalls, at 23.7%, were due to a mislabeling issue.

Q3 2017

  • The average number of medical device units involved in Class I recalls was 876,076 per quarter in 2017, nearly triple the 310,158 average in 2016. The average was 276,233 in 2015.

Q2 2017

  • 47.3% of recalls were for software or mislabeling – the same top causes as the previous two quarters.

  • 53% of recalls were distributed both domestically and internationally, the highest percentage since Q1 2016.

Try TVT for 30 days and see how worry-free the labeling and software creation can be for your next medical device project.


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