By Matt Walker, recall advisor The healthcare industry is changing to accommodate more modern demands, particularly those of patients who choose to self-treat. Over-the-counter (OTC) medications have risen in popularity recently, as patients increasingly seek more flexibility to take charge of their own health. For years, the U.S. Food and Drug Administration (FDA) has collaborated […]

Written by Chris Occleshaw, recall consultant According to Sedgwick’s 2023 State of the Nation Recall Index report, product recalls in five key European sectors increased in 2022 for the second consecutive year. The 10,545 recall events in 2022 represent a 4.3% increase over 2021 numbers for the automotive, consumer product, food and beverage, pharmaceutical, and […]

By Chris Harvey, VP, crisis solution Regulators in the United States have been moving especially quickly in the past year to implement new rules to protect children. With 2023 now well underway, companies should expect even more regulatory changes as federal agencies update their language and increase safety measures in consumer products. Safety hazards and […]

By Ryan Gooley The Food and Drug Administration (FDA) came under harsh criticism this past year after a commercial infant shortage formula in the U.S. For months, Congress and parent advocacy groups have been pressuring the agency to investigate why this crisis erupted in the spring and now an internal review of how the agency […]

By Julie Ross, International business development director The European Commission now seems to routinely extend the list of carcinogenic, mutagenic, or reprotoxic (“CMR”) substances that are prohibited for use in cosmetics throughout the EU. Most of these banned substances are relatively unknown, but a growing number are found in many cosmetic products. The most recent […]

By guest author, Nicola Smith Foreword by Julie Ross, international business development director at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and crisis communications experts across industries – on product safety issues that have the potential […]

By Jeremy Schutz Following a steady increase in reported deaths caused by faulty children’s products, the Consumer Product Safety Commission (CPSC) is under pressure to act more aggressively in pushing companies to recall products that pose a risk to children and toddlers. In 2021, the U.S. saw the second-highest number of reported deaths related to […]

By Ryan Gooley As COVID-19 begins to subside, the U.S. Food and Drug Administration (FDA), like other federal agencies is shifting its focus away from the pandemic and back toward more routine issues. As an example, the FDA recently published its final guidance outlining steps companies should take to develop recall policies and procedures that […]

By Amanda Combs, recall consultant Over the past few years, several drugmakers have had to recall blood pressure medications due to the presence of excess levels of nitrosamine. It’s happening again. Two major pharmaceutical companies have issued voluntary recalls of several tablet medications after routine testing found unacceptable levels of a specific carcinogen known as […]

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 The European Union’s “New Deal”, the Enforcement and Modernisation Directive, boosts consumer rights protection and updates e-commerce and digital content regulations. The directive also broadens the definition of product safety to include misleading marketing, enhanced transparency and cross-border infringements. Such a step can only lead to greater scrutiny and […]

By Mark Buckingham, recall advisor As electrical OEMs congratulate themselves on a bumper year for sales, many remain cautious about what 2022 holds in store as new right to repair regulations start to bite. In some respects, 2021 has been a good year for electrical appliance manufacturers. COVID has brought more investment in homes and […]

By Matt Walker, recall advisor Benzene, which has been discovered in several consumer products over the past year, has once again forced a voluntary recall. This time, it’s related to dry shampoo and dry conditioner spray products from various household brands. The recall is precautionary. No adverse reactions have been reported and experts say daily […]

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 Matt Walker Online pharmacy Valisure is warning that spray deodorants may be toxic to consumers — creating big problems and possible litigation threats to companies that aren’t paying attention. Valisure recently tested and detected unsafe levels of benzene, a cancer-causing human carcinogen, in spray antiperspirants and body sprays. This comes after several batches of spray sunscreen […]

By Mark Buckingham, recall advisor European consumers have always had a strong interest in health and wellness. But when it comes to vitamins and minerals, are they getting the treatment they deserve? During COVID-19, European’s use of dietary supplements more than doubled — from 31% to 69% — as people sought to boost their immune systems and […]

By guest authors: William Troutman, Kate Findlay and Hernan Gonzalez Foreword by Jeremy Schutz, director of business development at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and crisis communications experts across industries — on issues that […]

By Ryan Gooley Counterfeit goods have become increasingly problematic for the consumer product industry as more brands transition from traditional brick-and-mortar to online retail. The rise of counterfeit goods poses both a physical and financial threat, as they’re often made with poor materials or contain dangerous chemicals. Perhaps most alarming, a recent study from the Buy Safe […]

By Mark Buckingham, recall advisor With toys, clothing, medicine, motor parts and food all being pirated, the public is facing a growing global health risk when it comes to counterfeit products. Whilst fake goods often seem like an attractive bargain, they can be dangerous and hold links with organised crime. It is now estimated that 6.8% […]

By Luke Evans 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 impartial and reliable perspectives on past, present and future product safety trends, the index […]

by Chris Harvey, VP crisis solution 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 companies across all sectors are at an all-time high as consumer […]