Editor's Note The US Food and Drug Administration (FDA) has deemed Smiths Medical’s recall of Proport Plastic Implantable Ports a Class 1, the most severe designation indicating serious risk of injury or death. The devices are designed for repeated venous access for injections, infusions, and/or blood samples. According to the…

Read More

Editor's Note Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold, according to a March 5 early alert from the US Food and Drug Administration (FDA). The FDA notice concerns the Sigma Spectrum Infusion System…

Read More

Editor's Note The US Food and Drug Administration (FDA) designated Getinge’s recall of Vaporizer Sevoflurane Maquet Filling and Sevoflurane Quick-Fil and Philips’ recall of Tack Endovascular Systems as Class 1s, the most severe category indicating serious risk of injury or death. The Getinge recall is an expansion of a 2024…

Read More

Editor's Note A February 21 article in Modern Healthcare details how surgical robots are delivering faster procedures, improving patient outcomes, and boosting hospital profits. As detailed in the article, the global surgical robotics market has quadrupled since 2015, growing from $800 million to approximately $3 to $3.5 billion in 2023…

Read More

Editor’s Note The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could…

Read More

Editor's Note In an expansive session at the 2025 OR Business Management Conference, Tampa General Hospital's emergency management team demonstrated how proactive planning, strong partnerships, and real-time decision-making helped navigate multiple crises in 2024, including back-to-back hurricanes and a cyberattack on the state's blood supply. The session was presented by Erinn…

Read More

Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

Read More

Editor's Note The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain in adults. According to the agency’s January 30 announcement, the drug targets sodium channels in the peripheral nervous system to block pain signals before they reach the brain, representing…

Read More

Editor's Note The US Food and Drug Administration (FDA) designated Class 1 Recalls—the most severe category indicating serious risk of injury or death—for multiple devices over the past few days, including pressure monitoring systems, emergency resuscitators, fluid delivery sets, extracorporeal blood circuits, endoscope accessories, infusion pumps, and glucose/Ketone meters. These…

Read More

Editor’s Note Towana Looney, a 53-year-old Alabama woman, has become the longest-living recipient of a pig organ transplant, thriving 61 days after receiving a gene-edited pig kidney. The Associated Press (AP) reported the news January 25. As detailed in the article, her recovery offers critical insights into the development of…

Read More