Government oversight report calls for stronger FDA authority and training to respond to infant formula manufacturing problems in the future.
JUUL addiction risks and illegal marketing to teens previously led the FDA to call for a ban of the vape pens, and the manufacturer has paid nearly $3 billion to settle lawsuits brought by families, states and school districts nationwide.
FDA warns that problems with BioZorb Marker can cause users to suffer severe and potentially life-threatening complications from the bioabsorbable radiographic markers used for breast care and other exams
Manufacturer indicates that healthcare professionals should keep an alternative left ventricle assist device (LVAD) on standby in the event of a Heartmate 3 failure.
Federal health officials encourage anyone using the Tandem t:connect system to carefully monitor the battery levels to prevent unexpected pump failures, which could stop insulin delivery.
The agency is working to reduce children's exposure to lead and other heavy metals, according to testimony provided by FDA Administrator Califf
Further improvements to medical device quality, surveillance and the medical device recall program are planned by the FDA throughout 2024.
The FDA has announced yet another recall for HeartMate left ventricle assist systems, which have been linked to serious problems in recent years, and may have contributed to dozens of patient deaths.
The request must be assessed by the White House before being proposed for approval by the U.S. House and Senate.
The New Jersey production facility has a history or quality control problems over the last several years, according to FDA records.
