Magana Cathcart & McCarthy

60 Medical Devices Recalled by FDA in 2014

Medical Devices

From January 6th all the way to December 31st, medical devices were recalled by the U.S. Food and Drug Administration (FDA) in 2014 at the average rate of five per month. Below is a brief overview of some common problems found among medical products of various manufacturers:

  • Improperly sterilized equipment creating the possibility of microbial contamination and exposure to mold, bacteria and viruses
  • Suction tubing that may kink during use
  • Loss of power or software failure among various monitors, pumps, ventilators and other electrical equipment used during surgery
  • Parts prone to break off or detach during use
  • Product labeling promoting unproven medical claims
  • Particulate matter found in patient solutions
  • Incorrect flow rates and calculator errors in glucose meters and diabetes managers that could report erroneous results and lead to overdose or toxic results

The recalls posted by the FDA include only the most serious medical device recalls where there is a reasonable chance that use of the defective product could cause serious health problems or death. These recalls are almost all related to Class I medical devices. Recalls of Class II and Class III medical devices can be found by searching the Medical Device Recalls database. You can also sign up to receive e-mail alerts every time the FDA’s Medical Device Safety and Recalls webpage is updated.

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