Blog Articles
FDA Warns Against Use of Unapproved Epinephrine Nasal Solutions
The FDA has issued a warning to health care professionals about the dangers of using unapproved epinephrine nasal solutions manufactured by BPI Labs LLC and Endo USA. These products have been mistaken for FDA-approved injectable epinephrine due to similar packaging, leading to potentially dangerous medical errors. Unlike injectable epinephrine, nasal solutions are not sterile, and accidental intravenous injection can result in life-threatening infections.
Potential Exposure to HIV and Hepatitis at Vanderbilt Medical Center Raises Concerns of HIV, Hepatitis B and C.
Vanderbilt University Medical Center in Tennessee has notified endoscopy patients of a potential exposure to HIV and hepatitis B and C due to an infection control breach during endoscopic procedures. The issue involved improper administration of a solution through the scopes. While the risk of infection is described as “very low,” the exact number of affected patients has not been disclosed.
The FDA has reported an adverse event linked to the AIZU OLYMPUS EVIS EXERA III Duodenovideoscope (Model TJF-Q190V)
The FDA has reported an adverse event linked to the AIZU OLYMPUS EVIS EXERA III Duodenovideoscope (Model TJF-Q190V), a medical device used in endoscopic procedures. The report details a case involving four patients potentially affected by cross-contamination from the device, with one confirmed fatality. Key Details: Incident: Four patients underwent procedures with the same device in mid-2024.
FDA Issues Recall of Surgical Devices, Warns of Potential Shortage
The FDA has announced a recall of Maquet Cardiovascular’s VasoView HemoPro 1.5 and 1 endoscopic vessel harvesting (EVH) devices due to safety concerns. These devices, essential for harvesting blood vessels during procedures like coronary artery bypass graft (CABG) surgery, have been linked to reports of silicone parts detaching and remaining unrecovered in patients. This issue has already resulted in 17 serious injuries and procedural delays, sometimes requiring a more invasive open surgery.
The FDA Must Act: 400+ Tainted Drugs Still on the Market
The FDA has failed to withdraw more than 400 drugs that were approved based on fraudulent data from an Indian testing facility. Despite uncovering significant anomalies, the agency has allowed these medications—mostly generics—to remain available while pharmaceutical companies conduct new tests. Unlike the European Medicines Agency, which suspended these drugs immediately, the FDA has prioritized commercial interests over patient safety.
Percussionaire Recalls Phasitron 5 Breathing Circuits Over Nickel Exposure Risks
Percussionaire has issued an urgent recall of specific Phasitron 5 breathing circuits due to potential nickel exposure. This recall affects multiple part numbers, which were distributed to support intrapulmonary percussive ventilation (IPV) therapy for patients on mechanical ventilation. The FDA classified this recall as the highest risk level, as using affected devices may lead to severe adverse health issues, including lung injury, bronchospasm, allergic reactions, or even death.
Boston Scientific Updates Recall for Obsidio Blood-Blocking Agent Amid Safety Concerns
Boston Scientific’s Obsidio Conformable Embolic product, which is designed to block blood flow in emergency cases like gastrointestinal (GI) bleeds, is now associated with additional safety risks. After a February recall linked to seven injuries and two deaths, the FDA updated its notice in October, connecting Obsidio to four deaths and a total of 15 injuries.
Smith Medical, FDA recall listed as Class I (the most serious type), emphasizes immediate cessation of use and disposal or quarantine of affected products.
Smiths Medical has issued a recall for specific tracheostomy tube kits—including BLUselect, BLUgriggs, and BLUperc models—due to a manufacturing defect in which the pilot balloon may disconnect from the tracheostomy tube’s inflation line. This disconnection compromises the tube’s ability to maintain adequate pressure, leading to risks of insufficient ventilation, aspiration, or even fatal complications.
FDA issues Class I update on robotic arms due to risk of fire
Kinova has issued a serious correction for its Jaco Assistive Robotic Arm due to fire and burn risks associated with potential electrical issues. The correction does not involve removing the product but requires users and distributors to take specific actions to ensure safety. Affected Products The recall includes various models of the Jaco Assistive Robotic Arm, identified by specific serial numbers across all lots.
The FDA has approved Pfizer’s Abrysvo RSV vaccine.
The FDA has approved Pfizer’s Abrysvo as the first-ever RSV vaccine for adults aged 18 to 59, especially those with underlying chronic conditions that increase their risk of severe complications from the virus. These conditions include obesity, diabetes, COPD, asthma, heart failure, and chronic kidney disease. The vaccine had already been approved in May 2023 for adults over 60 and pregnant women, aimed at protecting newborns and infants.