Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
PORTEX Bivona Tracheostomy Silicone Tube Recalled by Smiths Medical ASD Inc. Due to Smiths Medical has identified that the securement flange...
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 Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
Why Was This Recalled?
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Where Was This Sold?
Worldwide distribution.
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