Integra LifeSciences and the U.S. Food and Drug Administration (FDA) are warning consumers about a recall of LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. This FDA medical device recall is a Class I recall, meaning that using these...
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...
Hamilton Medical Issues a Medical Device Recall over Software Defect
Hamilton Medical, a device maker based in Switzerland, issued a medical device recall of 4,300 ventilators because of a software error that shuts off the life-sustaining machines. The specific devices associated with this device recall are Hamilton G5 ventilators. The ventilators included in the recall were manufactured between November 29,...
What Does it Mean if FDA Enforcement is on the Decline?
The U.S. Food and Drug Administration (FDA) performs a vital function for the consumer by regulating and enforcing safety measures for food, medical devices, and pharmaceutical products. A recent study funded by Science Magazine suggests that the federal agency has been considerably less active in recent years. Is the decline...
FDA Won’t Honor FOIA Request to Release Undisclosed Medical Device Malfunctions
When Kaiser Health News (KHN) first reported on the hidden database of medical device recalls, the news agency submitted a Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA). The FDA said at that time that it would take almost two years to fulfill 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...
My Prescription is Included in a Medication Recall – What Should I Do?
If one of your prescriptions is included in a medication recall, you may be unsure of what to do. At Drug and Device Watch, we want our readers to be informed and feel confident about their medications and medical devices. Furthermore, we want you to understand potential dangers. Here is...