Smith Medical Removes Tracheostomy Tubes From Market as Part of Recall

Publish Date : 10/27/2024

Smiths Medical has recalled specific lots of its tracheostomy products—BLUselect Tracheostomy Tube Kits, BLUgriggs Percutaneous Dilation Tracheostomy Kits, and BLUperc Procedural Trays—due to a manufacturing defect causing the pilot balloon to disconnect from the tracheostomy inflation line. The recall is a Class I recall, the most serious type of recall. The defect can result in loss of cuff pressure, leading to inadequate ventilation and an increased risk of aspiration, potentially causing serious health issues or death.

Smiths Medical issued an Urgent Medical Device Notification to customers, advising them to discontinue use, quarantine or dispose of affected products, and complete a customer response form. The affected devices are intended for adults needing an artificial airway due to trauma or other medical conditions.