Medical device makers issued more than 400 recalls during Q2, 30% more than in the previous quarter. That’s higher than reported for the last 5 quarter, according to a report by Stericycle ExpertRECALL
The recalls affected about 9.2 million units, a 50% decrease in the quantity of products affected in Q1. Four recalls affected between 500,000 and 1 million units each, and no single recall affected more than 1 million products.
The recalls launched during the 2nd quarter, nearly half of which included an international component, were issued by 174 companies, about 34% of which issued more than 1 recall during the period. One unnamed company posted 17 recalls and 6 others posted 10 or more apiece, according to the report.
About 80% of the posted recalls were Classified by the FDA as Class II, a lower-risk category defining "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
The rest of the recalls were split pretty evenly between Class II, referring to situations where adverse events are unlikely, and Class I, for recalls "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."
Read more of MassDevice.com’s coverage of medical device recalls.
Stericycle analysts warned that, with medical device recalls occurring more frequently and on much larger global stages, manufacturers need to ensure they’re prepared to deal with the varying regulatory requirements for recalls in different nations.
"Scalability will be critical for medical device manufacturers facing product recalls going forward, and it’s one of the reasons why ExpertRECALL has recently expanded its global capabilities," Stericycle ExpertRECALL vice president Mike Rozembajgier said in prepared remarks. "Safety in global distribution and supply chains has no boundaries. Companies should implement recall plans that prepare for the increased complication and regulatory oversight that they or their vendors will have to navigate during an international product recall."
