The First Quarter 2018 “Recall Index” published by Stericycle Expert Solutions (“Stericylce,” which “provides global and local expertise before, during, and after a recall threat” and each quarter of the year analyzes cumulative recall data across five product categories), reported increases in both pharmaceutical recalls and medical device recalls in the First Quarter of 2018.
Stericycle reported for First Quarter 2018: “Pharmaceutical recalls increased 52% to 105 – the highest since Q3 2013 and the third highest since at least 2005. Recalled units jumped more than 100 times to nearly 332.5 million units – the highest quarter by far since Q2 2007 and second highest since 2005. This is mostly due to one large recall.”
Stericycle further reported:
1. Failed specifications made up the top cause of recalls for the seventh consecutive quarter (21.9%).
2. 84 companies reported at least one recall in Q1 2018 – the highest number since at least 2012.
3. Class I recalled units increased for the second quarter in a row – this time by 192.8%. There were more than 1 million Class I recalled units in Q1 2018 – higher than any quarter from 2016 and three of the quarters in 2017.
79% of the pharmaceutical recalls were nationwide.
97.8% of the pharmaceutical recalls were Class II recalls.
The FDA defines a Class I recall as a situation in which there is a reasonable probability that the product will cause serious adverse health consequences or death.
The FDA defines a Class II recall as a situation in which the product could cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The FDA defines a Class III recall as a situation in which the product is not likely to cause adverse health consequences.
Medical Devices Recalls
Stericyle reported for First Quarter 2018: “Medical device recalls increased 126% to 343 – more than double last quarter and the largest quarter since at least 2005. Recalled units increased to about 208.4 million – 4.5 times higher than the previous quarter, 45 million larger than any quarter since at least 2005, and higher than all of 2017 combined.”
Stericycle further reported:
1. The average recall size was 607,512, up considerably from last quarter’s 245,862 and higher than any quarter since Q3 2007.
2. 22.7% of recalls were for software, making it the top cause for the eighth consecutive quarter.
3. Recalls of products distributed both domestically and globally dropped to 36%, lower than any quarter since at least 2012.
55% of the medical device recalls were nationwide.
93.7% of recalled medical device units were due to manufacturing defects (the top cause for medical device recalls for the second quarter in a row, largely due to one recall).
If you or a loved one suffered harm due to a defective medical device or a defective pharmaceutical product in the United States, you should promptly consult with a medical device claim lawyer, or a pharmaceutical product claim lawyer, in your U.S. state who may investigate your defective medical device claim or defective pharmaceutical product claim for you and represent you in a claim, if appropriate.
Visit our website or call us toll-free in the United State at 800-295-3959 to find lawyers in your state who may assist you.
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