Medline Recalls Neonatal/Pediatric Kits Containing Smiths Medical ET Tubes

Medline Industries LP has recalled neonatal and pediatric convenience kits that contain recalled Smiths Medical Oral/Nasal Endotracheal Tubes, according to an FDA alert.

The recalled tubes may have a smaller diameter than expected, which may prevent the patient from receiving proper ventilation, the FDA says.

The use of these affected products may cause serious adverse health consequences, including lack of oxygen (hypoxia) that may lead to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death, according to the alert.

Medline neonatal and pediatric convenience kits are used for various medical procedures including intubation. The Smiths Medical Oral/Nasal Endotracheal Tubes included in these kits help keep air flowing through a patient’s airway. They are inserted in the mouth (oral) and/or the nose (nasal) when someone needs to be intubated to maintain airway patency and support ventilation.

The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The FDA says that Medline Industries has reported eight injuries related to this issue. There have been no reports of death

FDA Recommendations:

On April 4, 2025, Medline Industries, LP, sent customers a letter recommending the following actions:  

• Check inventory and stop use of affected product.  
• Return the destruction form included with the letter listing the number of affected kits to be destroyed. Return this form even if there is no affected product.
  • Credit will be issued after Medline Industries receives the completed form.  
• Destroy all affected kits in inventory.  
• Notify anyone who may have received affected products through a transfer from the organization.
  • Request customers destroy affected product.  
  • Include customer’s destroyed product quantities on the organization’s destruction form.

Affected Products