AIRFIT F30IRecalls & reported problems across all models
Resmed Pty Ltd · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one AIRFIT F30I model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 10 models of AIRFIT F30I by Resmed Pty Ltd in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between May 3, 2024 and Nov 8, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AIRFIT F30I recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 20, 2023Class IOpen, Classified
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Z-0542-2024 · Root cause: Device Design · names 9 of these models · Recall details · FDA record ↗
Most reported AIRFIT F30I problems
Device problems
- Break2
- Electromagnetic Interference2
Patient problems
- Confusion/ Disorientation2
- Dizziness2
- Fall2
- Irritability2
- Loss of consciousness2
- Memory Loss/Impairment2
- No Clinical Signs, Symptoms or Conditions2
- Psychosis2
AIRFIT F30I models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AIRFIT F30I 63332Ventilator, Non-Continuous (Respirator)1 recall2 reports
- AIRFIT F30I 63300Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63301Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63305Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63306Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63330Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63331Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63333Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63334Ventilator, Non-Continuous (Respirator)1 recall0 reports
- AIRFIT F30I 63370Ventilator, Non-Continuous (Respirator)2 reports
Recent AIRFIT F30I adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED TO RESMED THAT THE MAGNETS OF AN AIRFIT F30I MASK ALLEGEDLY CAUSED THE SETTINGS OF A PATIENT'S ADJUSTABLE MAGNETIC VENTRICULOPERITONEAL SHUNT TO SHIFT RESULTING IN TOO MUCH FLOW OF CEREBROSPINAL FLUID. PATIENT REQUIRED TRANSPORT TO THE HOSPITAL. PATIENT HAS SWITCHED TO A NON-MAGNETIC MASK. PATIENT DID NOT HAVE SYMPTOMS PRIOR TO USE OF THE MASK.
Patient problems: Confusion/ Disorientation; Dizziness; Fall; Irritability; Loss of consciousness; Memory Loss/Impairment; Psychosis
MAUDE report 20645928 ↗InjuryNov 8, 2024Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED TO RESMED THAT THE MAGNETS OF AN AIRFIT F30I MASK ALLEGEDLY CAUSED THE SETTINGS OF A PATIENT'S ADJUSTABLE MAGNETIC VENTRICULOPERITONEAL SHUNT TO SHIFT RESULTING IN TOO MUCH FLOW OF CEREBROSPINAL FLUID. PATIENT REQUIRED TRANSPORT TO THE HOSPITAL. PATIENT HAS SWITCHED TO A NON-MAGNETIC MASK. PATIENT DID NOT HAVE SYMPTOMS PRIOR TO USE OF THE MASK.
Patient problems: Confusion/ Disorientation; Dizziness; Fall; Irritability; Loss of consciousness; Memory Loss/Impairment; Psychosis
MAUDE report 20644726 ↗MalfunctionMay 3, 2024Break; Break
IT WAS REPORTED TO RESMED THAT A PIECE OF AN AIRFIT F30I MASK BROKE OFF WHILE IN USE ON A PATIENT. IT WAS REPORTED THAT THE PATIENT MAY HAVE SWALLOWED THE BROKEN PIECE DURING THE NIGHT WHILE ASLEEP. THERE WAS NO REPORT OF THE PATIENT SEEKING MEDICAL ATTENTION OR TREATMENT DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243327 ↗MalfunctionMay 3, 2024Break; Break
IT WAS REPORTED TO RESMED THAT A PIECE OF AN AIRFIT F30I MASK BROKE OFF WHILE IN USE ON A PATIENT. IT WAS REPORTED THAT THE PATIENT MAY HAVE SWALLOWED THE BROKEN PIECE DURING THE NIGHT WHILE ASLEEP. THERE WAS NO REPORT OF THE PATIENT SEEKING MEDICAL ATTENTION OR TREATMENT DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243325 ↗
Other Resmed Pty Ltd products
- Astral3 models · 3,253 reports · 1 recall
- AIRFIT N 107 models · 0 reports · 1 recall
- AirTouch N209 models · 0 reports · 1 recall
- AIRFIT N2013 models · 0 reports · 1 recall
- AIRFIT F2012 models · 0 reports · 1 recall
- AirTouch F2016 models · 0 reports · 1 recall
- AirFit F305 models · 0 reports · 1 recall
- AIRSENSE5 models · 44 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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