HUDSON RCI IPN913776Recalls & reported problems
Teleflex Incorporated · CONCHA NEPTUNE · Class 2
All models of HUDSON RCI (152)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Teleflex Concha Neptune respiratory humidifier has 436 adverse event reports, with no injuries and no deaths. The reports mostly describe the heater not warming up, the unit failing to power on or losing power, and temperature control problems. Most reports record no effect on the patient. No recalls name 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
- 436
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 14026704646811), received between Jan 25, 2021 and Oct 28, 2021 — classified as 436 malfunctions.
The most frequently reported specific device problem is “Insufficient Heating” (162 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.
Most reported problems
Device problems
- Insufficient Heating162
- Failure to Power Up93
- Complete Loss of Power62
- Device Alarm System38
- Temperature Problem29
- Intermittent Loss of Power6
- Power Problem6
- Failure to Read Input Signal5
Patient problems
- No Clinical Signs, Symptoms or Conditions397
- Insufficient Information45
Recent adverse event reports
The 25 most recent of 436 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2021Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED ""HEATER RANDOMLY SHUTS DOWN WHILE IN USE". IT WAS CONFIRMED, "IT WAS NOTICED IMMEDIATELY AT SETUP AND THE HEATER WAS SWAPPED OUT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712824 ↗MalfunctionOct 28, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "NEPTUNE HEATER FAILS TO WARM UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712712 ↗MalfunctionOct 28, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "NEPTUNE HEATER FAILS TO WARM UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712699 ↗MalfunctionOct 28, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "NEPTUNE HEATER FAILS TO WARM UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712685 ↗MalfunctionOct 28, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "NEPTUNE HEATER FAILS TO WARM UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712657 ↗MalfunctionOct 20, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE UNIT IS "NOT POWERING ON". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12668762 ↗MalfunctionOct 19, 2021Temperature Problem; Temperature Problem
IT WAS REPORTED "UNABLE TO ADJUST TEMPERATURE. HEATER ALARMS THEN RESETS ONCE IT REACHES 29 DEGREE CELSIUS". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12656264 ↗MalfunctionOct 19, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED THE UNIT "DOES NOT HEAT UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12656118 ↗MalfunctionOct 19, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED THE UNIT IS "NOT HEATING". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12655869 ↗MalfunctionOct 19, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED THE UNIT IS "NOT HEATING". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12655850 ↗MalfunctionOct 18, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED THAT THE UNIT "WOULD NOT HEAT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647034 ↗MalfunctionOct 18, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED THAT THE UNIT "WOULD NOT HEAT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647018 ↗MalfunctionOct 18, 2021Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED "HEATER PERIODICALLY SHUTS DOWN AT RANDOM". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12646941 ↗MalfunctionOct 15, 2021Temperature Problem; Temperature Problem
IT WAS REPORTED THE UNIT IS "NOT MAINTAINING TEMPERATURE". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639624 ↗MalfunctionOct 15, 2021Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THE UNIT "POWERS OFF RANDOMLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639592 ↗MalfunctionOct 15, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED THAT THE UNIT IS "NOT MAINTAINING TEMP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639572 ↗MalfunctionOct 15, 2021Complete Loss of Power; Complete Loss of Power
IT WAS REPORTED THE UNIT "KEEPS TURNING OFF". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639540 ↗MalfunctionOct 15, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "UNIT IS NOT HEATING PROPERLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639491 ↗MalfunctionOct 15, 2021Complete Loss of Power; Complete Loss of Power
IT WAS REPORTED "BROKEN UNIT. THE HEATER TURNS ON BUT DOESN'T STAY ON". NO INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639454 ↗MalfunctionOct 12, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED "THE HEATER IS NON-FUNCTIONAL (WILL NOT TURN ON)". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12617187 ↗MalfunctionOct 8, 2021Complete Loss of Power; Complete Loss of Power
IT WAS REPORTED THE UNIT "POWERS ON AND THEN TURNS OFF". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12597909 ↗MalfunctionOct 8, 2021Complete Loss of Power; Complete Loss of Power
IT WAS REPORTED THE UNIT "POWERS ON AND THEN TURNS OFF". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12597885 ↗MalfunctionOct 8, 2021Complete Loss of Power; Complete Loss of Power
IT WAS REPORTED THAT THE UNIT "POWERS ON AND THEN TURNS OFF". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12597867 ↗MalfunctionOct 6, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "THE UNIT WILL NOT HEAT UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12585031 ↗MalfunctionOct 6, 2021Insufficient Heating; Insufficient Heating
IT WAS REPORTED "THE UNIT WILL NOT HEAT UP". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12584955 ↗
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-1115-2020 · Dec 13, 2019 · TerminatedHUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
- Z-1114-2020 · Dec 13, 2019 · TerminatedHUDSON RCI COMFORT FLO Humidification System, REF 2410, 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
- 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
- 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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