Compliance Management

Pharma Recalls Down in Q3; Medical Device Recalls Up

Nov 15, 2016

Stericycle

The Stericycle ExpertSOLUTIONS Q3 Recall Index highlights the influence of today’s rapid pace of innovation on recall activity, with technology-related recalls in medical devices, consumer goods and automotive industries.

Medical device recalls reached their highest level since 2000, due in large part to software issues, according to the latest Q3 2016 U.S. Recall Index. The race to innovate more advanced medical devices no doubt improves quality of life for many patients, but advancements are also vulnerable to recalls. Of the 116 million medical devices recalled last quarter (representing a 187 percent increase), more than 48 percent were due to software or mislabeling errors.

Pharmaceutical recalls were down significantly – 20 percent – and recalled units were consistent with previous quarters, dropping 3 percent. Class III products accounted for 57 percent of recalled units, a change from Q2 when Class II products were the largest percentage.

The Stericycle Recall Index is the only report that aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA and the USDA. For more information, please visit www.stericycleexpertsolutions.com/thought-leadership.