The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
According to the U.S. Food and Drug Administration records, in an average year over 2,500 medical device recalls are issued in the United States. Some of these recalls simply require checking the ...
A report published this week by the recall consulting group ExpertRecall analyzing the number of recalls in the regulated healthcare product sector shows that both pharmaceutical and medical device ...
The Food and Drug Administration lacks adequate staffing to oversee medical device recalls, according to a report released Friday by the U.S. Government Accountability Office. The report, which ...
Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: AirLife/Vyaire ...
The stakes are high when it comes to medical device safety, but recall notifications aren’t always easy to find. With this in mind, a new Boston-based startup called Soom is aiming to target this ...
An urgent recall has gone out for a popular medical device used by millions of Americans with diabetes. The US Food and Drug Administration (FDA) has revealed that over two million blood glucose ...
This article originally appeared on ProPublica. The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it’s sometimes ...
Medical device recalls are intended to act as a hard stop. When a defect is identified, products are removed from use, hospitals are notified, and patients are protected. At least, that is how the ...
Zoll Circulation is recalling its AutoPulse NXT Resuscitation System due to a failure code that can result in stopped or inadequate chest compressions. The malfunction may delay lifesaving CPR and ...