Vapotherm Inc.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Regulator, Pressure, Gas CylinderProduct code CAN (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.2700
Recalls & enforcement
- Class IIOngoing2022-12-16There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.
- Class IITerminated2014-08-13Disposable Patient Circuit that allows water to leak into the center gas lumen
Related
- All facilities operated by VAPOTHERM, INC.
- Vapotherm-Mexico S de RL de CV (MX)
- Baja Fur S.A. de C.V. (MX)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Vapotherm Inc. (FEI 3012971441) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012971441-vapotherm-inc/
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