Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
The Tri-Flo Subglottic Suction System Recalled by Vyaire Medical Due to Foreign Object Contamination
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 Vyaire Medical directly.
Affected Products
The Tri-Flo Subglottic Suction System
Quantity: 2150 Units Total
Why Was This Recalled?
Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
Where Was This Sold?
This product was distributed to 18 states: AZ, CA, CT, FL, GA, IL, IN, IA, MD, MA, MN, NJ, OH, OK, SD, TX, WA, WI
About Vyaire Medical
Vyaire Medical has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report