Class I Recall of Defective Infant Warmers

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of GE Healthcare's Giraffe and Panda i-Res infant warmers.  A Class I recall is the most serious class given to defective medical devices. The recall instructs medical professionals in hospitals and other clinical settings to inspect the...

What Are Medical Device Recalls?

The U.S. Food and Administration (FDA) reports on, monitors, and enforces medical device recalls for public safety.  But, what does that really mean? What exactly is a medical device recall and how do recalls affect consumers? Let’s take a look. Medical Device Recalls A recall means that the FDA and/or...

FDA Recalls Medtronic Insulin Pumps Due to Hacker Risk

The U.S. Food and Drug Administration (FDA) issued a warning to patients and the medical community about Medtronic MiniMed insulin pumps because some of the devices are vulnerable to hackers.  FDA recalls for cybersecurity problems are rare even though the agency and other experts have expressed concerns about medical device...

FDA Regulation of Medical Devices: How Safe are We?

The U.S. Food and Drug Administration (FDA) is a federal regulatory agency responsible for monitoring and reporting on food, pharmaceutical, and medical devices.  A series of widespread injuries caused by FDA-approved drugs and medical devices - coupled with a damning scandal about their hidden database that distorts safety information -...