Shortages of medical devices were not particularly topical before the COVID-19 pandemic, but they have dotted the landscape in the past three years despite the U.S. FDA’s best efforts to manage such ...

The closing of an ethylene oxide sterilization plant in Illinois has led to a temporary shortage of Bivona tracheostomy tubes manufactured by Smiths Medical, the US Food and Drug Administration (FDA) ...

On Wednesday, ICU Medical Inc’s (NASDAQ:ICUI) subsidiary, Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes. The FDA classified the recall as the ...

Smiths Medical has recalled and removed Bivona neonatal/pediatric and adult tracheostomy tubes due to a manufacturing defect that can cause the securement flange of the device to tear, which can cause ...

ICU Medical Inc.’s ICUI subsidiary, Smiths Medical, has issued a recall for certain Bivona neonatal and adult tracheostomy tubes due to a defect in the securement flange, which can lead to tear and ...