Home › Device types › BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
FDA product code BTT · Class 2 · Anesthesiology
1,043
Registered devices
18,067
Adverse events
70
Recalls
221
510(k) clearances
Devices with this code
HUDSON RCI — TELEFLEX INCORPORATEDAPEX — Wellell Inc.Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDF&P Optiflow+ — FISHER & PAYKEL HEALTHCARE LIMITEDNeonatal Single Heated Wire Breathing System 1.25m with 1 x Water Trap — FLEXICARE MEDICAL LIMITEDFisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDN/A — SALTER LABSHUDSON RCI — TELEFLEX INCORPORATEDVapotherm — VAPOTHERM, INC.Vapotherm — VAPOTHERM, INC.Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDAPEX — Wellell Inc.HUDSON RCI — TELEFLEX INCORPORATEDTemperature Probe — FISHER & PAYKEL HEALTHCARE LIMITEDHygrovent Gold Basic — FLEXICARE MEDICAL LIMITEDFisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDMR850 — FISHER & PAYKEL HEALTHCARE LIMITEDFisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDMISTIC — PEGASUS RESEARCH CORPORATIONVapotherm — VAPOTHERM, INC.HUDSON RCI — TELEFLEX INCORPORATEDFisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDAirLife™ — AIRLIFEHUDSON RCI — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Medline Industries, LP | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discolorat |
| 2025-09-18 | Fisher & Paykel Healthcare, Ltd. | When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible ale |
| 2024-04-02 | Fisher & Paykel Healthcare, Ltd. | Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result |
| 2022-12-16 | Vapotherm | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow Syste |
| 2021-01-05 | Hamilton Medical AG | When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water i |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the wa |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the wa |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the wa |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the wa |
| 2015-04-01 | Teleflex Medical | Customer complaints were received of power to the unit ceasing and the display going blank. |
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