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Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year 

Mike Rozembajgier
By Mike RozembajgierMedical device recalls saw a dramatic 160 percent increase in the first quarter of 2012, according to the first quarterly ExpertRECALL™ Index of 2012.From alcohol prep pads, to needles, and latex gloves, medical device recalls affected nearly 82 million units, a 508 percent increase over the previous quarter –  a five-quarter high. Joining this rise in recall activity were consumer products. Pharmaceutical recalls and food product recalls declined.

What is the cause behind the recent surge in medical device recalls?

While the quarter-over-quarter increase in medical device recalls may seem surprising at first glance, it should be expected given that recalls documented in fourth quarter 2011 U.S. Food and Drug Administration (FDA) Enforcement Reports were at an unprecedented low.

What is more alarming is the number of companies who are becoming repeat offenders and the large increase of units these recalls are affecting. With more and more Americans relying on these devices to maintain and improve their health and life, companies would be smart to reiterate their number-one priority – consumer and patient safety. Especially given that the media has been paying close attention to medical device safety and scrutinizing the government’s approval process. FDA has even responded to such criticisms by publicly reassuring its dedication to device safety.

The ExpertRECALL Index examines recall trends and issues that affect consumers and manufacturers alike. Additional takeaways from first-quarter findings in the ExpertRECALL Index include:

  • 150 million units were recalled by pharmaceutical companies in the first quarter of 2012, recording a five-quarter high.
  • First quarter Enforcement Reports saw a 90 percent decrease in the number of units affected by food recalls.
  • 35 million units were affected by consumer product recalls across all 15 product categories.
  • Recalls of children’s and infant products affected 1.1 million units during the first quarter.

You can read the full ExpertRECALL Index here. What first-quarter findings surprise you the most?  How do you believe FDA will react to the ongoing scrutiny it faces from consumer advocates and the media about its approval process? Your thoughts are most welcome.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.