Regulatory Focus™ > News Articles > Group: Medical Device, Pharmaceutical Recalls Down Significantly

Group: Medical Device, Pharmaceutical Recalls Down Significantly

Posted 24 February 2012 | By Alexander Gaffney, RAC 

A recent study shows that both medical device and pharmaceutical recalls were down significantly over the fourth quarter of 2011, decreasing 63% and 35% respectively.

The study, conducted by Stericycle ExpertRECALL, found that medical devices only experienced 106 recalls in the fourth quarter of 2011. This was down 63% from the previous quarter and 57% from the previous year. Recalls primarily affected Class II medical devices, accounting for 93% of all device types and 99% of all recalled units.

The study also found that pharmaceutical product recalls were down from the prior quarter, but were higher than average. Recalls decreased 35% in the fourth quarter of 2011, but increased 36% over the fourth quarter of Q4 2010.

Ninety-seven pharmaceutical products representing 92 million units were recalled in Q4 2011. Broken down by risk:

  • Class I - Dangerous Products - 11%
  • Class II - Risky Products - 63%
  • Class III - Defective/Mislabeled - 26%

Several products accounted for the majority of product recalls, including two that accounted for more than 10 million units each.


Read more: Stericycle Expert RECALL Quarterly Recall Index - Fourth Quarter 2011


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