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 ...

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

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 ...

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

Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...

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.

Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal. The ...

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