Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.
FDA MedWatch
Early Alert: Infusion Pump Software Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years
The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo
Early Alert: Blood Pump Controller Issue from Abiomed
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.
Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Import Alerts for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.