Smiths Medical recalls airway tubes because of defect linked to more than 10 injuries

Smiths Medical has recalled tracheostomy kits, including the Portex Bluselect, Blugriggs, and Bluperc kits, due to a manufacturing defect that may cause the balloon to detach from the inflation line. This recall affects over 850,000 units, as reported in FDA database entries. In a customer letter from June, Smiths indicated receiving more than 10 reports of serious injuries related to this issue.

So far this year, Smiths has experienced seven Class I recalls, which are issued for products posing a serious risk of injury or death. Following its acquisition by ICU Medical in 2022 for $2.35 billion, Smiths has faced ongoing quality challenges, including a warning letter in 2021.

The recall specifically concerns tracheostomy tubes that aid breathing when airways are blocked. Smiths instructed customers to discard affected products and contact them for replacements. Additionally, a separate recall was issued in May for another tracheostomy tube line, linked to one death and 35 injuries.