The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Walnut Wearable Smart Thermometer Product Model Number: WT20 Product Lot Number: 20221115W002 Devices Recalled in the U.S.: 979 Dates Distributed: December 1, 2022 – April…
Think Before You Ink: Tattoo Safety
Image Español Tattoos are more popular than ever. About 30% of all Americans, and 40% of those aged 18-34 years old, have at least one tattoo, according to polling by the firm Ipsos. While state and local authorities oversee the practice of tattooing, inks and pigments used in tattoos are subject to U.S. Food and…
How Sweet It Is: All About Sweeteners
Image Español Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people choose sweeteners other than sugar. Sweeteners such as aspartame, sucralose, and stevia-derived substances, for example, are widely used ingredients in foods and beverages marketed as “sugar-free” or “diet.” Some of the products…
Oxygenator Devices Used for Extracorporeal Circulation – Letter to Health Care Providers
June 9, 2023 The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on the use of oxygenators in extracorporeal circulation. On May 18, 2023, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Getinge/Maquet Venous Hardshell Cardiotomy…
Qué tan dulce es: todo sobre los edulcorantes
Image English Ya sea para reducir la cantidad de calorías que consumen o por cualquier otro motivo, algunas personas eligen edulcorantes diferentes del azúcar. Los edulcorantes como el aspartamo, la sucralosa y las sustancias derivadas de la estevia, por ejemplo, son ingredientes muy utilizados en alimentos y bebidas comercializados como “sin azúcar” o “dietéticos”. Algunos…
FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On April 19, 2023, the FDA approved polatuzumab vedotin-piiq, brand…
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Impella 5.5 with SmartAssist Product Code: 0550-0008 Product Serial Numbers: See Recall Database Entry Distribution Dates: September 28, 2021 to March 6, 2023 Devices Recalled…
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies – Letter to Health Care Providers
June 5, 2023 The U.S. Food and Drug Administration (FDA) is aware of health care facilities and providers experiencing localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs in the United States. These devices are mainly used in elective limb surgeries and in emergency and trauma settings. During interruption in the supply of these devices,…
Don’t Use Products Marketed to Treat Molluscum, a Common Skin Condition
Image Español If you’re bothered by bumps on your skin, don’t try to diagnose yourself or treat your condition with products that haven’t been approved by the U.S. Food and Drug Administration. Instead, visit a health care professional for a proper diagnosis and to make a treatment plan. One common condition that some people try…
ACTUALIZACIÓN: Uso del dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicación de seguridad de la FDA
English Fecha de publicación: 10 de mayo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando otra actualización sobre el sistema de dispositivos Renuvion/J-Plasma de Apyx Medical con respecto al uso del dispositivo para ciertos procedimientos estéticos de la piel y una autorización adicional…