Regulatory Focus™ > News Articles > Report: 'Dramatic' Increase in Q1 Medical Device Recalls

Report: 'Dramatic' Increase in Q1 Medical Device Recalls

Posted 14 May 2012 | By Alexander Gaffney, RAC 

A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls.

Medical device recalls increased 160% from Q4 2011 through Q1 2012 while the number of recalled units increased 508%, writes Mike Rozembajgier of the recall tracking company ExpertRECALL.

The number of recalls was the most since 2010. While the increase was "dramatic," it also comes after an "unprecedented" dearth in recalls, noted Rozembajgier. As Regulatory Focus reported at the time, Q4 2011 medical device recalls had fallen 63% from the previous quarter.

"What is more alarming," explains Rozembajgier,  "is the number of companies who are becoming repeat offenders and the large increase of units these recalls are affecting." "One-third of companies facing recalls in the first quarter of 2012 were involved in more than one recall," according to the report.

Class II recalls continued to constitute the majority of recalls-a fact largely consistent with 2011 trends.

The report also tracked pharmaceutical recalls, which exhibited markedly different trends than did medical devices.

Recalls of pharmaceutical products hit a five-quarter low, though those recalled products were for more units than recalls of previous quarters, accounting for 150 million recalled units. This is likely because of a small handful of over-the-counter (OTC) products being recalled. Despite only fourteen OTC products being recalled, those products accounted for 141 million (94%) of the recalled units.

Many pharmaceutical companies faced numerous recalls (9 of 52) during Q4 2011, though not to the same extent as medical device companies.


Read more:

ExpertRECALL Quarterly Recall Index

Regulatory Focus - Group: Medical Device, Pharmaceutical Recalls Down Significantly

Medical Device Recalls Soar During First Quarter, ExpertRECALL Index Shows: Consumer Product Recalls Also Rise; Pharmaceutical and Food Recalls Decline

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

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