RECALL ALERT
Ongoing
XLSX-4E8EEC594F
Bivona: Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)
Recalled by Smiths Medical
Classification
—
Reason for Recall
The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Product Details
Product Quantity
Not specified
Product Type
Food
Code Info
Not specified
Voluntary/Mandated
Not specified
Distribution & Geography
Distribution Pattern
Not specified
Company Location
Not specified
Timeline
Report Date
09/04/2024
Recall Initiated
09/04/2024
Classification Date
N/A
Termination Date
N/A
Source: U.S. Food & Drug Administration (FDA) — FDA Recalls
Last updated: August 29, 2026
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