HUDSON RCI IPN049807Recalls & reported problems
Teleflex Incorporated · MICRO MIST® Nebulizer with Elongated Adult Aerosol Mask and 7ft Star Lumen® Tubing · Class 2
All models of HUDSON RCI (152)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Teleflex Micro Mist nebulizer, used with an adult aerosol mask and tubing to deliver inhaled mist, is the subject of 62 reports. Most describe the nebulizer failing to deliver mist or producing less mist than expected, along with tubing that disconnects, leaks, or breaks. No deaths or injuries are reported. There are 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
- 62
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 14026704645920), received between Jan 22, 2021 and Feb 2, 2023 — classified as 62 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (46 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.
Most reported problems
Device problems
- Failure to Deliver46
- Disconnection10
- Leak/Splash3
- Break1
- Improper Flow or Infusion1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2023Break; Break
REPORTED EVENT: THE DOCTOR FOUND THE TUBE BROKEN WHEN USING IT ON THE PATIENT. IT WAS CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16283306 ↗MalfunctionJul 25, 2022Improper Flow or Infusion; Improper Flow or Infusion
THE COMPLAINT REPORTED THAT: THE PATIENT NEEDS TO BE AEROSOL INHALED AFTER SURGERY, AND IS GIVEN AEROSOL INHALATION ACCORDING TO THE STANDARD PROCEDURE. THE MIST OUTPUT IS SMALL; IMMEDIATE CORRECTION BY HOSPITAL: REPLACE WITH A NEW NEBULIZER."
Patient problems: Insufficient Information
MAUDE report 15095073 ↗MalfunctionNov 2, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND NO MIST WHEN USING ON PATIENT". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12737537 ↗MalfunctionSep 17, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND NO MIST WHEN USING ON PATIENT". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12488069 ↗MalfunctionAug 10, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND LESS MIST WHEN USING ON PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300533 ↗MalfunctionAug 10, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND LESS MIST WHEN USING ON PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300505 ↗MalfunctionAug 10, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED, "THE NEBULIZER WAS FOUND NOT MISTING WHEN USING ON PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300476 ↗MalfunctionAug 5, 2021Disconnection; Disconnection
IT WAS REPORTED "THE NURSE WAS PREPARING TO ATOMIZE THE PATIENT, AND WHEN THE PRODUCT WAS ASSEMBLED, IT WAS FOUND THAT THE CONNECTING PORT OF THE PRODUCT CONNECTING TUBE AND THE BOTTOM OF THE MEDICINE CUP SLIPPED NATURALLY DURING INSTALLATION, AND IT COULD NOT BE CONNECTED AND USED NORMALLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12280861 ↗MalfunctionAug 5, 2021Disconnection; Disconnection
IT WAS REPORTED "THE NURSE WAS PREPARING TO ATOMIZE THE PATIENT, AND WHEN THE PRODUCT WAS ASSEMBLED, IT WAS FOUND THAT THE CONNECTING PORT OF THE PRODUCT CONNECTING TUBE AND THE BOTTOM OF THE MEDICINE CUP SLIPPED NATURALLY DURING INSTALLATION, AND IT COULD NOT BE CONNECTED AND USED NORMALLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12280829 ↗MalfunctionAug 5, 2021Disconnection; Disconnection
IT WAS REPORTED "THE NURSE WAS PREPARING TO ATOMIZE THE PATIENT, AND WHEN THE PRODUCT WAS ASSEMBLED, IT WAS FOUND THAT THE CONNECTING PORT OF THE PRODUCT CONNECTING TUBE AND THE BOTTOM OF THE MEDICINE CUP SLIPPED NATURALLY DURING INSTALLATION, AND IT COULD NOT BE CONNECTED AND USED NORMALLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12280800 ↗MalfunctionAug 5, 2021Disconnection; Disconnection
IT WAS REPORTED "THE NURSE WAS PREPARING TO ATOMIZE THE PATIENT, AND WHEN THE PRODUCT WAS ASSEMBLED, IT WAS FOUND THAT THE CONNECTING PORT OF THE PRODUCT CONNECTING TUBE AND THE BOTTOM OF THE MEDICINE CUP SLIPPED NATURALLY DURING INSTALLATION, AND IT COULD NOT BE CONNECTED AND USED NORMALLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12280770 ↗MalfunctionJul 23, 2021Disconnection; Disconnection
IT WAS REPORTED THAT "THE NURSE WAS PREPARING TO ATOMIZE THE PATIENT, AND WHEN THE PRODUCT WAS ASSEMBLED, IT WAS FOUND THAT THE CONNECTING PORT OF THE PRODUCT CONNECTING TUBE AND THE BOTTOM OF THE MEDICINE CUP SLIPPED NATURALLY DURING INSTALLATION, AND IT COULD NOT BE CONNECTED AND USED NORMALLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12220472 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT"THE NEBULIZER WAS FOUND NO MIST WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196359 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND NOT MISTING IN THE CLINICAL SETTING BEFORE USE ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196314 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND LESS MIST WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196264 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND MISTING LESS DURING CLINICAL SETTING BEFORE USE ON PATIENT". NO PATIENT INVOLVEMENT RE PORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196229 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND MISTING LESS DURING CLINICAL SETTING BEFORE USE ON PATIENT". NO PATIENT INVOLVEMENT RE PORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196183 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND NO MIST WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196149 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE NEBULIZER WAS NOT MISTING IN THE CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196103 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE NEBULIZER WAS NOT MISTING IN THE CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196080 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT "THE NEBULIZER WAS FOUND LESS MIST WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196054 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE NEBULIZER WAS FOUND LESS MISTING IN THE CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196008 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE NEBULIZER WAS FOUND LESS MISTING IN THE CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12195977 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE NEBULIZER WAS FOUND LESS MISTING IN THE CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12195950 ↗MalfunctionJul 20, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE NEBULIZER WAS FOUND LESS MIST IN THE CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12195922 ↗
Other NEBULIZER (DIRECT PATIENT INTERFACE) devices
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
- Portex Z110-14Icu Medical, Inc. · NEBULIZER (DIRECT PATIENT INTERFACE)5 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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