HUDSON RCI IPN040673Recalls & reported problems

Teleflex Incorporated · HUMID VENT MINI STERILE · Class 1

All models of HUDSON RCI (152)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 11
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04026704347810), received between Jun 3, 2021 and Feb 10, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Moisture or Humidity Problem” (10 reports).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Moisture or Humidity Problem10
Detachment of Device or Device Component1
Fluid/Blood Leak1

Patient problems

Unspecified Respiratory Problem10
Ventilator Dependent1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342295 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342280 ↗
MalfunctionFeb 10, 2025Fluid/Blood Leak; Moisture or Humidity Problem; Fluid/Blood Leak; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342257 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00046, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342238 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342228 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342218 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342175 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342119 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21342108 ↗
MalfunctionFeb 10, 2025Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT: "CHILDREN TRY TO TAKE IT OFF, WHICH IS A RISK. CUSTOMER THINKS THIS ITEM GETS WET TOO EASILY AND THAT IS WHY CHILDREN TRY TO TAKE THEM OFF BY THEMSELVES." ASSOCIATED COMPLAINTS 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 AND 8040412-2025-00048.
Patient problems: Unspecified Respiratory Problem
MAUDE report 21341970 ↗
MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT " WE HAVE HAD A FAMILY ON CASELOAD WHO HAS HAD ISSUES WITH THE HUMID-VENT, THEY HAVE BEEN USING THEM FOR A WHILE. THEY HAD RANG TO HAVE MORE STOCK AS THE WHITE FILTER WAS FALLING OUT SO WAS INEFFECTIVE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: Ventilator Dependent
MAUDE report 11934976 ↗

Device details

UDI-DI	`04026704347810`
Brand	HUDSON RCI
Model	IPN040673
Catalog no.	10011
Company	Teleflex Incorporated
Product code	BYD · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 7, 2025

Device type (GMDN): Heat/moisture exchanger, single-use

A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

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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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