Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes Recalled by Smiths Medical ASD Inc. Due to Carton labeling is printed with "Sterile" indicated labeling,...
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
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Quantity: 16 units
Why Was This Recalled?
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Where Was This Sold?
This product was distributed to 8 states: CA, FL, GA, ID, NJ, NM, OH, VA
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