RegWardenFDA facility compliance records
Facility

Vapotherm-Mexico S de RL de CV

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2022: 1 recalls1’14’15’16’17’18’19’20’211’22’23’24’25’26
  • Recalls (2)

Devices registered here (1)

  • Humidifier, Respiratory Gas, (Direct Patient Interface)
    Product code BTT (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5450

Recalls & enforcement

  • Class IIOngoing2022-12-16
    There 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 IITerminated2014-08-13
    Disposable Patient Circuit that allows water to leak into the center gas lumen

Related

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-Mexico S de RL de CV (FEI 3048101987) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3048101987-vapotherm-mexico-s-de-rl-de-cv/

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