Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless Recalled by Smiths Medical ASD Inc. Due to One lot of 3.0mm Bivona Cuffless Adjustable Neck...
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
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Quantity: 20 devices
Why Was This Recalled?
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Where Was This Sold?
This product was distributed to 4 states: MS, NE, TN, TX
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