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# Smiths Medical Recalls Bivona Tracheostomy Tubes
- URL: https://www.fdaweb.com/smiths-medical-recalls-bivona-tracheostomy-tubes/
- Published: 2024-09-18T12:00:00.000Z
- Updated: 2026-09-14T14:41:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157809

Smiths Medical is recalling (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect that may cause the device’s securement flange to tear. “The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of a protected airway, and death,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/tracheostomy-tube-recall-smiths-medical-removes-certain-bivona-neonatalpediatric-and-adult?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. To date, there have been 35 reported injuries, and two death reports.

The Bivona tubes are used to provide direct airway access for a patient with a tracheostomy for up to 29 days. Some tubes can be reprocessed and re-used several times for a single patient, according to the notice.