HUDSON RCI HUD2410Recalls & reported problems
Medline Industries, Inc. · HUMIDIFICATION SYSTEM, COMFORT FLO · Class 2
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197344009589), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Increase in Pressure” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure1
- Leak/Splash1
Patient problems
- Choking1
- Cough1
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Leak/Splash; Increase in Pressure; Leak/Splash; Increase in Pressure
ACCORDING TO THE FACILITY, ON (B)(6) 2025, WHEN PATIENT WAS USING COMFORT FLOW HUMIDIFICATION SYSTEM, THERE WAS A "SUDDEN BURST OF WATER AND PRESSURE" AND THE "PATIENT STARTED CHOKING AND COUGHING AS WATER SPRAYED IN FACE."
Patient problems: Choking; Cough; Low Oxygen Saturation
MAUDE report 23865321 ↗
Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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