Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vapotherm Precision Flow Recalled by Vapotherm, Inc. Due to Disposable Patient Circuit that allows water to leak...
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 Vapotherm, Inc. directly.
Affected Products
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Quantity: 865 units
Why Was This Recalled?
Disposable Patient Circuit that allows water to leak into the center gas lumen
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vapotherm, Inc.
Vapotherm, Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report