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Compliance In Focus
Posted by John Lehmann on Thu, Mar 20, 2014

Record High Medical Device Recalls in 2013

Why in 2013 was there a record number of product recalls in the medical device industry?  TheRecord High Medical Device Recalls in 2013 FDA claims the increase is due to manufacturers over-reporting and the increasing sensitivity to media reports about product problems, not due to, but because of an increase in medical device problems.

Product recalls can have a potentially devastating impact on medical device manufacturers.  Obviously, the cost of a recall can be high, but it can also shake customer loyalty.

Here is a recap of the facts for 2013:

  • A total of 1,138 recalls were published by the FDA’s Enforcement Report
  • This represents a 9% increase from 2012
  • The previous high was 1,046 reported in 2012
  • In 2011, there were 957 recalls

Ann Ferriter, director of the Division of Analysis and Program Operations from the CDRH’s Office of Compliance, states that once a company has been cited by the FDA for failing to report a recall – or not reporting in a timely fashion – they tend to be more proactive in reporting everything that might be considered a correction or removal. They tend to over report according to Ferriter.

She also claims that manufacturers of certain devices tend to over report recalls.  “AEDs (automated external defibrillators), ventilators, radiological devices and infusion pumps have all been in the press over the past few years.” 

Ferriter maintains that if you eliminate the over-reporting after being cited and the AED, ventilators, radiological devices and infusion pumps, that the number of recalls since 2002 has actually been flat.

Are you concerned about the increase in product recalls is on an upward trend?  Or do you agree with the FDA’s explanation of the increase?  Please share your thoughts with us.

Photo Credit: Ari Herzog

Documentation in Devices

Topics: Medical Device Manufacturers, FDA, CDRH, Product Recalls


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