While the brand originally initiated the recall in December, the FDA just recently classified the recall as a Class II, meaning “a situation in which use of, or exposure to, a violative product ...

The US Food and Drug Administration has approved the use of a novel painkiller as an effective treatment for short-term ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

However, on January 14, 2025, the FDA reclassified the recall as Class II, which it defines as "a situation in which use of or exposure to a violative product may cause temporary or medically ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

Here are three recent recalls reported to the FDA: ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

Today, the FDA oversees countless products that affect our health and wellness, including food, tobacco, cosmetics, prescription drugs, vaccines, over-the-counter drugs, medical devices ...

The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect ...

Class II medical devices are named “Notification”, because ... will go live on 21st September. FDA has started its review of an autoinjector version of Eisai and Biogen's Alzheimer's drug ...