Class II — Vapotherm, Inc.
| Recalling firm | VAPOTHERM, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Product | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the 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 | 22042 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy. |
| Initiated | 2014-08-13 |
| Classified | 2014-09-25 |
| Terminated | 2015-10-02 |
| Recall number | Z-2703-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vapotherm, Inc. (Z-2703-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69116/
Alerts for VAPOTHERM, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.