Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube Recalled by Smiths Medical ASD Inc. Due to A specific model and lot number of Bivona...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD Inc. directly.
Affected Products
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Quantity: 238 devices
Why Was This Recalled?
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smiths Medical ASD Inc.
Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report