Johnson & Johnson MedTech and Oscor, the company’s manufacturing partner, received reports of the sheaths leaking in ways that could result in access-site bleeding. 

These systems do not need to be returned to the manufacturer. However, users are urged to follow specific instructions to avoid any issues.

Customers are urged not to use these devices due to a risk of tip separation. The FDA first warned the public about this issue in July.

The new recall includes multiple lots of dabigatran etexilate capsules.

Novartis recalled a single lot of valsartan, a blood pressure/heart failure drug the company sells under the brand name Diovan. According to the FDA, this is a Class II recall.

The recall was announced after testing revealed the presence of potentially harmful particulate matter. Customers were urged to return any unused vials immediately.

More than 750,000 devices are included in the new Class II recall. At this time, however, no devices need to be returned to the manufacturer.