The FDA classified the recall of certain tubes made by a unit of ICU Medical as the most serious type, which could cause severe injury or death.

Specific lots of the tubes sold under the Bivona brand by ICU's unit Smiths Medical for neonatal or pediatric and adult patients are being recalled due to a manufacturing defect that may cause the device's securement flange to tear.

ICU Medical did not immediately respond to a request for comment.

The regulator said use of affected products may cause serious health consequences, including lack of proper ventilation, loss of a protected airway and death.

There have been 35 reported injuries, and two reports of death, the FDA said.