Update: Reduce the Risk for Medical Device Misconnections

February 24th, 2023|

Today, the U.S. Food and Drug Administration (FDA) added a new case study to its “Examples of Medical Device Misconnections” webpage. The webpage describes device misconnections based on reports of adverse events received by the FDA and includes tips to reduce these types of events from occurring. The new case study involves an air inflation

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication

October 9th, 2019|

The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities is already publicly

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall

December 3rd, 2018|

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s