Quality Magazine

Medical Device Recalls Soar During First Quarter

May 17, 2012

INDIANAPOLIS-- Medical device recalls increased more than 160% in the first quarter of 2012, affecting more than five times as many units than the previous quarter, according to the quarterly ExpertRecall.

Products impacted by the increase include alcohol prep pads, catheters, needles and latex gloves. Consumer product recalls also increased in the first quarter of 2012. Conversely, the ExpertRecall Index found that pharmaceutical and food recalls decreased compared with previous quarters.

Medical device recalls documented in first quarter U.S. Food and Drug Administration (FDA) Enforcement Reports affected nearly 82 million units, representing a 508% increase over the previous quarter and recording a five-quarter high. Additionally, about one-third of companies that faced recalls in the first quarter were involved in more than one recall event-a trend that has continued over the last five recent quarters.

"While the quarter-over-quarter increase in medical device recalls is significant, this change was not all that unexpected given that recalls documented in fourth quarter 2011 Enforcement Reports were at an unprecedented low," explains Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. "However, what is troublesome is the dramatic increase in units affected by the recalls and continued number of repeat offenders. It's scary to think about given the increasing number of devices that American patients rely on to maintain and improve their health. Consumer and patient safety should be the number-one priority for every manufacturer, distributor, retailer, doctor's office and healthcare facility."

"Companies should be doing everything possible to minimize the safety concerns that would result in recalls," Rozembajgier says. "Similarly, any business or individual within a supply chain, whether a distributor or a doctor, should keep close tabs on the products they handle to ensure that potential safety concerns are identified early and reported to the manufacturer and the regulatory agency. This due diligence ensures that the impact of recalls, when they do happen, is minimized. Ultimately fewer units, and thus fewer consumers, will be affected."

The ExpertRECALL Index also found that while pharmaceutical recalls hit a five-quarter low, the recalls documented in FDA Enforcement Reports affected more units than in the previous four quarters. Of the recalls documented, 20% affected over-the-counter drugs while 80% affected prescription medications.

Consumer product recalls initiated at the request of the Consumer Product Safety Commission (CPSC) increased 24% quarter-over-quarter with fire hazards as the leading cause of recalls. While the consumer product category overall logged more recalls compared with the previous quarter, recalls of children's products reached a five-quarter low and accounted for just 13% of CPSC recalls.

Food recalls documented in first quarter FDA Enforcement Reports decreased 19%. Of first quarter recalls, 56% earned the FDA's most severe "Class I" designation.

The 2012 first-quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the CPSC and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by the U.S. Food and Drug Administration and the Consumer Product Safety Commission. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex.