Medical device recalls fell 4.4% in Q2 2023 to 241 events, with quality concerns accounting for the majority of recalls for the first time since Q1 2016, according to the latest recall data from Sedgwick. The number of units recalled also decreased in Q2 2023, down 20.3% to 66.4 million.
Sedgwick expects technology in medical devices will be a key focus for regulators and other stakeholders in the remainder of 2023. The FDA has issued draft guidance related to facilitating the marketing approval process for artificial intelligence and machine learning- (AI/ML) enabled devices. The FDA, as well as other regulators such as the FTC, are addressing concerns around data security breaches and cybersecurity in medical devices, which will likely result in new guidelines or regulations for manufacturers.
“Evolving risks from emerging technologies like artificial intelligence, as well as increased scrutiny from consumers will introduce new challenges for manufacturers, even as they continue to contend with stricter oversight from regulators,” said Chris Harvey, Sedgwick senior vice president of brand protection. “As regulators look to expand product liability beyond manufacturers to include retailers and operators of secondary marketplaces, thorough and well-tested recall and crisis response plans will become crucial to weathering in-market challenges.”
U.S. recall activity has returned to pre-pandemic levels according to Sedgwick, which shows there were more than 850 recall events for the second quarter in a row. While recall events fell less than 1% in Q2 2023 compared to the previous quarter, they still remain higher than all the previous quarters between Q1 2019 and Q4 2022, according to Sedgwick brand protection’s latest U.S. product recall index report, which analyzes recall data from five key industries.
The number of defective units recalled in Q2 2023 increased 13.7% compared to Q1 2023. The total number of recalled units in the first two quarters of 2023 may not be enough to reach the necessary threshold for a third consecutive record-breaking year for the number of units recalled. However, with more than 439 million units recalled between January and June 2023, and if current trends continue, we may see the number of units recalled at least surpass one billion yet again in 2023.
Released quarterly, Sedgwick’s recall index report offers in-depth analysis of the latest product recall data, safety regulations, and key challenges for the automotive, consumer product, food and drink, medical device, and pharmaceutical industries. Featuring analysis and perspectives from Sedgwick’s brand protection experts and network of strategic partners, the index is a key resource in helping mitigate recall risk, litigation, and reputational damage caused by product crises and in-market events.