HUDSON RCI HUD42500Recalls & reported problems
Medline Industries, Inc. · NEPTUNE HEATED HUMIDIFIER,CONCHASMART · Class 2
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medline Neptune heated humidifier, used with ConchaSmart, warms and moistens breathing gas for patients who need respiratory support. The 58 reports mostly describe the unit not heating properly, shutting down on its own, or failing to power up, along with alarms and power issues; two reports mention a burn. There are 57 reports in the past 12 months and none in the prior12 months, with no deaths and no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 87
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10197344010806), received between Jul 14, 2024 and Sep 30, 2026 — classified as 2 injuries, 85 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (33 reports).
3 other recalls cover devices cleared under the same FDA submission (K131912); they may or may not involve this specific model.
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
- Unexpected Shutdown33
- Insufficient Heating14
- Excessive Heating12
- Device Alarm System8
- Electrical /Electronic Property Problem4
- Failure to Power Up4
- Power Problem4
- Defective Alarm3
Patient problems
- No Clinical Signs, Symptoms or Conditions86
- Burn(s)1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953810 ↗MalfunctionSep 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952831 ↗MalfunctionSep 30, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952828 ↗MalfunctionSep 30, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952347 ↗MalfunctionSep 30, 2026Break
It was reported that "THE UNIT IS BROKEN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952341 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952337 ↗MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951045 ↗MalfunctionSep 30, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950993 ↗MalfunctionSep 30, 2026Insufficient Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950824 ↗MalfunctionSep 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950441 ↗MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948560 ↗MalfunctionSep 30, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948358 ↗MalfunctionSep 30, 2026Calibration Problem; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948168 ↗MalfunctionSep 30, 2026Defective Alarm
It was reported that I have 1 Neptune heater that is not working correctly. Problem = Wrench.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947210 ↗MalfunctionSep 30, 2026Insufficient Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947184 ↗MalfunctionSep 30, 2026Insufficient Heating; Unexpected Shutdown
It was reported that "all 3 are just no longer heating."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946785 ↗MalfunctionSep 30, 2026Defective Alarm
No water alarm, not clearing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946440 ↗MalfunctionSep 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946397 ↗MalfunctionSep 30, 2026Unexpected Shutdown
It was reported that "Turns off (shuts down)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946279 ↗MalfunctionSep 30, 2026Power Problem
It was reported that Neptune power button is broken. Unit turns on then off while in use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945758 ↗MalfunctionSep 30, 2026Unexpected Shutdown
It was reported that the device ¿Will not stay on.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945689 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that "Heated wire alarms."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945484 ↗MalfunctionSep 29, 2026Insufficient Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940132 ↗MalfunctionSep 29, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939944 ↗MalfunctionSep 29, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938788 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131912. One submission often covers many models, so check the product and lot details in each record.
- Z-1114-2020 · Dec 13, 2019 · TerminatedHUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
- Z-1115-2020 · Dec 13, 2019 · TerminatedHUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
- Z-1558-2015 · Apr 1, 2015 · TerminatedTeleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
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
- 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
- F&P Optiflow Junior 2 OJR414Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)56 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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