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 therapeutic approval. On December 18, 2024, the FDA approved remestemcel-L-rknd (brand name…
Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Fresenius Kabi USA has…
Update: Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
January 16, 2025 The U.S. Food and Drug Administration (FDA) is providing an update on its evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators. Based on the FDA’s review of the totality of the available information including testing data, we have determined that all new neonatal incubators…
Avoid Queso Fresco-Type Cheeses if You’re in High-Risk Groups
Image The U.S. Food and Drug Administration recommends pregnant people, adults aged 65 and older, and people who have weakened immune systems avoid eating all queso fresco-type cheeses. The recommendation is included in updated consumer education materials from FDA’s Human Foods Program. Queso fresco-type cheeses are highly susceptible to the bacteria (germ) Listeria, which can…
Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
The devices described in this recall are included in the related Letter to Health Care Providers. See the Letter to Health Care Providers for the most current information on these devices. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has…
Animal Welfare, Testing and Research of FDA-Regulated Products
Image Medical and veterinary products save lives every day. FDA-regulated products such as blood pressure medicine, chemotherapy and MRI machines help people and animals live longer and healthier. The U.S. Food and Drug Administration regulates human and animal medical products to ensure they are safe and effective. Products undergo different types of testing to determine…
Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care Impact
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Monitoring Service Application for Mobile…
Create and Keep a Medication List for Your Health
[embedded content] Spanish Many people of all ages take medications. Keeping track of when, how and why you use medications is important for your health and safety. A medication list is a tool to help you keep track of all the prescription medications, over-the-counter (OTC) drugs, vitamins and supplements that you take. Keeping a medication…
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
[Posted 1/7/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning…
Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product and Allegedly Counterfeit Product Product Names: Batteries for use in Plum 360, Plum A+, and…