HUDSON RCI IPN049808Recalls & reported problems
Teleflex Incorporated · Pediatric MICRO MIST® Nebulizer with Elongated Pediatric 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
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704645937), received between Feb 25, 2021 and Apr 26, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (4 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 Deliver4
- Disconnection1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT "THE TUBE BURST DURING USING ON PATIENT,THE NURSE CHANGED NEW ONE IMMEDIATELY, NO IMPACT ON PATIENT". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11727290 ↗MalfunctionMar 22, 2021Disconnection; Disconnection
IT WAS REPORTED THAT "AFTER THE ATOMIZATION INHALATION TREATMENT FOR THE PATIENT WAS COMPLETED, THE CONNECTION TUBE OF THE ATOMIZATION SPRAY DEVICE WAS DETACHED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11546426 ↗MalfunctionFeb 25, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE DOCTOR FOUND NO MIST DURING CLINICAL INSPECTION BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11382219 ↗MalfunctionFeb 25, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE DOCTOR FOUND NO MIST DURING CLINICAL INSPECTION BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11382186 ↗MalfunctionFeb 25, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE DOCTOR FOUND NO MIST DURING CLINICAL INSPECTION BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11382181 ↗MalfunctionFeb 25, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "THE DOCTOR FOUND NO MIST DURING CLINICAL INSPECTION BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11382180 ↗
Other NEBULIZER (DIRECT PATIENT INTERFACE) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- 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 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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