Recalls Up, Says ExpertRECALL Report

ExpertRECALL, a recall consulting form owned by Stericycle Inc., recently released its third quarter report for 2013, detailing the state of medical device recalls for the quarter.

According to the report, the U.S. Food and Drug Administration (FDA) documented 415 medical device recalls in Q3, an increase of 1 percent over the same quarter last year. There were approximately 29 million units recalled in the third quarter, a dramatic increase of 215 percent from the previous quarter, resulting in the highest level of units affected in the past five quarters. Two recalls affected more than three million units, 13 recalls affected between 500,000 and one million units, and 400 recalls affected less than 500,000 units.

“There are a number of reasons for recall events, which is why it’s important to have strong supply chain management and quality control while maintaining strong relationships with suppliers and being informed of current and changing regulations to minimize the risk of a recall,” Mike Rozembajgier, vice president of recalls at ExpertRECALL, told Medical Product Outsourcing.

171 companies issued recalls in the quarter. Out of these, 36 percent issued more than one recall. Once company issued 23 individual recalls, and nine companies announced 10 or more recalls each.

Medical device recalls documented during Q3 affected both domestic and international customers. Three hundred recalls impacted customers nationwide. There were also 236 recalls that affected customers in the
United States and at least one other country or territory.

“Safety has, for a number of years, been a priority concern for the United States, which is why recalls are so regular in the United States,” explained Rozembajgier. “More and more countries are updating their recall criteria, so companies doing business globally should be aware of the regulations governing where their products are sold.”

The ExpertRECALL Index analysis also revealed the following:

• ·       The number of Class I units recalled increased by more than 485 percent during the third quarter;
• ·       The number of Class II units recalled increased over 50 percent during the third quarter as well;
• ·       90 percent of recalls were classified as Class II, an 8 percent increase from the previous quarter;
• ·       Despite only a slight increase in the number of recalls this quarter, the number of total units recalled increased by 215 percent from last quarter. This figure represents the highest number of units recalled in the last five quarters;
• ·       Approximately 36 percent of companies that engaged in a recall faced more than one, a trend that has continued from previous quarters;
• ·       The number of international medical device recalls rose from last quarter by more than 19 percent, reaching 57 percent this quarter;
• ·       And one company faced 23 recall events in the third quarter, which marked a 35 percent increase from the highest number of recall events faced by one company last quarter.

Class I recalls are issued, according to the FDA, in a situation in which there is a “reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” In this instance, the recalling company informs its customers and requires that they inform their customers. Class II recalls are for products that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote; and Class III is reserved for products that are compromised but not likely to cause adverse effects such as illness or death.

“[ExpertRECALL] continues to emphasize the importance of being prepared and being able to respond at a moment’s notice,” concluded Rozembajgier “Prevention is key, but in the event of a recall—especially if a company puts forth its full effort—it can reduce harm and the irreparable reputation damage that follows a poorly handled recall.”