By Mark Buckingham, recall advisor According to our latest European product recall index report, the overall number of recall events in Europe fell 8.8% in the third quarter, compared to Q2. The pharmaceutical sector experienced the greatest decline, registering 25.0% fewer events. This was followed by medical device (at 10.2%), food and beverage (at 10.0%), […]

By Chris Harvey, VP, crisis solution As supply chains become more disrupted, regulatory environments more complex, and economic forecasts more uncertain than ever before, companies face increased product liability concerns and exposures. According to our latest U.S. recall index report, the number of products recalled in 2022 has officially reached a 20-year high. Released quarterly, […]

By Chris Harvey, VP, crisis solution The total number of U.S. products recalled this year has now topped 1 billion, according to our latest U.S. product Recall Index. More than 1 billion units have been recalled only twice before in history, in 2018 and 2021. However, it took a full year to reach the benchmark during […]

By Chris Occleshaw, recall consultant Even as many countries eased pandemic-related restrictions, recent events have introduced a new host of challenges and risks for the five key industries surveyed in our latest edition of the European Recall Index report. Our report includes analysis of recall data from Q1 2022 across 5 key industries: automotive, consumer product, food […]

By Chris Harvey, VP, crisis solution The U.S. Food and Drug Administration (FDA) recently finalized a guidance document outlining how companies and stakeholders should become “recall ready” to minimize buyers’ and users’ exposure to potential health risks. The Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C includes recommended preventative procedures that makers and distributors […]

By Julie Ross, International business development director and Luke Evans, business development manager As we enter the third calendar year of the COVID-19 pandemic, regulators are adapting to the “new normal.” As reported in our latest edition of the recall index report, product recalls rose by over a quarter (25.5%) across key European industries in 2021 […]

By Chris Harvey, VP, crisis solution While regulators and business leaders enter the third calendar year of COVID-19, some new challenges are emerging atop the lingering supply chain and service issues brought on by the pandemic. The Biden administration continues to push for more consumer safeguards as medical device recalls rise and regulators consider stricter […]

By Matt Walker, recall advisor The US Food and Drug Administration (FDA) has turned its attention to the development and regulation of medical devices unique to women’s health. The FDA’s Center for Devices and Radiological Health (CDRH) recently finalized its Health of Women Program Strategic Plan. The plan, initially proposed in September 2019, looks to protect […]

By Matt Walker, recall advisor Cybersecurity has become a critical issue for the medical device industry, where a cyber threat can lead to injury or even death. To address this growing problem, the U.S. Food and Drug Administration, the MITRE Corporation, and the Medical Device Innovation Consortium (MDIC), have published a playbook that offers insights to organizations […]

By Chris Harvey, VP, crisis solution We are living through a perfect storm of heightened business risks that are impacting every industry — from labor shortages, supply chain issues and inflation to increased regulatory oversight and enforcement. When combined, these risks pose substantial regulatory and litigation threats to nearly every business, as reported in the […]

By Julie Ross, International business development director As we emerge from one of the most turbulent and uncertain times in recent history, consumers are eager for a return to normal and economists are predicting a boom as we approach the holiday season. But with so much uncertainty still ahead, it seems the only thing we […]

By Matt Walker Following the lead of the European Union and Great Britain, the U.S. FDA has begun rolling out its action plan for regulating artificial intelligence/machine learning (AI/ML)-based software as a medical device. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) recently released its regulatory program for medical devices, which bears many similarities to […]

The number of product recalls initiated by medical device makers continued a steady decline in the second quarter of 2021, the number of recalled device units shot through the roof. Read MedTech Insight’s summary of these recalls, or download Sedgwick’s complete Q2 Recall Index Report for expert analysis and perspective on all the trends shaping safety regulations in […]

The global response to the coronavirus crisis put a bright spotlight on the complexity of global supply chains. But not only in the traditional, “behind-the-scenes” way we think about companies sourcing inputs, component parts and ingredients. It also highlighted the risks and vulnerabilities facing consumers when they are uninformed about quality issues, potential fraud or […]