Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in s…
Data from the first quarter of 2023 shows that product recalls across the U.S. automotive, consumer product, food and beverage, medical device, and pharmaceutical industries increased 14.2% from the previous quarter. As reported in Sedgwick brand pro…
European product recalls increased 6.1% in the first quarter of 2023, according to Sedgwick brand protection’s latest European recall index report. In total, the European automotive, consumer product, food and beverage, pharmaceutical, and medical de…
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. Th…
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 yea…
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 consu…
While there’s light at the end of the COVID-19 tunnel and consumers anticipate a return to normal, ‘business-as-usual’ is still a long way off, as reported in our 2021 Recall Index report. Essential reading for manufacturers and retailers seeking i…
As regulators, businesses and organizations emerge from the global pandemic, each is struggling to find its path to a new “new normal.” Most are finding it’s a rocky path. Significant questions and uncertainty persist, and reputational risks to compa…
COVID-19 may have stalled huge sectors of the global economy, but regulatory oversight in the U.S. remains vigilant and may even be picking up its pace as we move through the third quarter. In fact, medical device recalls in the second quarter reach…
The Medicines and Healthcare products Regulatory Agency (MHRA) leads the charge on assuring the safety of medicines, medical devices and blood components for transfusion in the UK. Its core job is to ensure the products meet applicable standards of s…
Today’s complex high-tech devices continue to cause cybersecurity vulnerability issues, but it’s the medical devices that live on or inside patients, like implants and pacemakers, that are posing a special challenge for the healthcare industry. The …
The COVID-19 pandemic has resulted in an unprecedented, global demand for personal protective equipment (PPE), with several countries placing export bans on the sale of PPE and costs increasing by up to 1000%. In the past month, alerts for PPE pla…
Across the globe, nations are doing whatever they can in the fight against the COVID-19 pandemic. And while different strategies are being used in different countries, the use of medical devices to combat the virus is well-known with ventilators, med…
The faster a new medical device is approved, the sooner it’s likely to be recalled, according to a new research letter published in JAMA Internal Medicine. While the authors admit the data and findings have limitations, two conclusions they draw are …
While U.S. product recalls were relatively flat from the second to the third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unreg…