HUDSON RCI IPN049826Recalls & reported problems
Teleflex Incorporated · ISO-NEB FILTERED NEBULIZER SYSTEM · Class 1
All models of HUDSON RCI (152)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704661463), received between Oct 18, 2021 and Oct 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
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 Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED "INVOLVED A (B)(6) YEAR-OLD FEMALE PATIENT - WEIGHT (B)(6) KG. PATIENT CAME TO THE HOSPITAL TO GET HER SPECIFIC NEBULIZER. DURING THE SETTING UP OF THE KIT, THERE WAS NONE OR ALMOST NO TREATMENT MIST". NEW DEVICE USED. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12646757 ↗
Other NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) devices
- LMA ATOMIZATION IPN915303Teleflex Incorporated · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)18 reports
- LMA ATOMIZATION IPN048826Teleflex Incorporated · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)11 reports
- Salter AIRE Elite 8350-8900Salter Labs · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)8 reports
- Salter AIRE Elite SO-1774BESalter Labs · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)7 reports
- N/A 8904-7Salter Labs · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)5 reports
- LMA ATOMIZATION IPN049182Teleflex Incorporated · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)1 report
- AirLife™ 441HAirlife · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)1 report
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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