Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube Recalled by Smiths Medical ASD Inc. Due to Smiths Medical became aware that one lot of...
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¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Quantity: 142
Why Was This Recalled?
Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.
Where Was This Sold?
This product was distributed to 20 states: CA, CO, CT, FL, GA, LA, MD, MA, MI, MN, MO, NE, NC, OK, PA, SC, TN, TX, WA, WI
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