AirLifeRecalls & reported problems across all models
Vyaire Medical, Inc. · 25 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 25 models of AirLife by Vyaire Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2020 and Jan 2, 2026 — classified as 19 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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. 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
Most reported AirLife problems
Device problems
- Leak/Splash8
- Connection Problem6
- Disconnection5
- Loose or Intermittent Connection5
- Material Too Rigid or Stiff3
- Break2
- Incomplete or Inadequate Connection2
- Partial Blockage2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Low Oxygen Saturation7
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Pressure Sore/Ulcer3
- Bradycardia1
- Decreased Respiratory Rate1
- Distress1
AirLife models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AirLife™ 001350CANNULA, NASAL, OXYGEN5 reports
- AirLife™ 002002HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)5 reports
- AirLife™ 002450Nebulizer (direct patient interface)4 reports
- AirLife™ SFT2601Conserver, oxygen4 reports
- AirLife 004081Connector, Airway (Extension)4 reports
- AirLife™ 001302CANNULA, NASAL, OXYGEN3 reports
- AirLife™ 002438Nebulizer (direct patient interface)2 reports
- AirLife™ 001365CANNULA, NASAL, OXYGEN2 reports
- AirLife™ FM2699Conserver, oxygen2 reports
- AirLife™ 002446Nebulizer (direct patient interface)1 report
- AirLife™ 002601Conserver, oxygen1 report
- AirLife™ 002003HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)1 report
- AirLife™ 001320CANNULA, NASAL, OXYGEN1 report
- AirLife™ 001362CANNULA, NASAL, OXYGEN1 report
- AirLife™ 001203MASK, OXYGEN, NON-REBREATHING1 report
- AirLife™ 001262CANNULA, NASAL, OXYGEN1 report
- AirLife™ 001303CANNULA, NASAL, OXYGEN1 report
- AirLife™ 001363CANNULA, NASAL, OXYGEN1 report
- AirLife™ 002430Nebulizer (direct patient interface)1 report
- AirLife™ 001840CANNULA, NASAL, OXYGEN1 report
- AirLife™ SFT2692Conserver, oxygen1 report
- AirLife™ SFT2699Conserver, oxygen1 report
- AirLife™ 557055200CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)1 report
- AirLife™ 3215CONNECTOR, AIRWAY (EXTENSION)1 report
- AirLife™ 004083CONNECTOR, AIRWAY (EXTENSION)1 report
Recent AirLife adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2026Incomplete or Inadequate Connection
MED SUN MW REPORT MW (B)(4) REPORTED, "INFANT WAS SLEEPING IN RADIANT WARMER AND HAVING PHOTOGRAPHS TAKEN WHEN THIS RN SAW THAT INFANT BEGAN DESATURATING AND SATTING IN THE 70S. DUE TO A HISTORY OF THESE DEVICES FAILING, THIS RN IMMEDIATELY LOOKED TO SEE IF THE NASAL CANNULA HAD FALLEN OFF OF THE HUMIDIFIER AND IT HAD. NASAL CANNULA WAS RE-SECURED TO THE HUMIDIFIER. SATURATIONS IMPROVED IMMEDIATELY."
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 23952221 ↗MalfunctionNov 19, 2025Break; Break
IT WAS REPORTED: THE OXYGEN CONNECTOR THAT "TEE'D" INTO THE OXYGEN TO THE PATIENT'S CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) SNAPPED OFF. THERE WAS NO APPARENT HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601288 ↗InjuryNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3004748541-2025-00124 FOR THE SECOND REPORT REFER TO 3004748541-2025-00125 FOR THE THIRD REPORT. MED SUN USER FACILITY MDR REPORT -(B)(4) REPORTED: INFANT WAS DESATURATING AND REGISTERED NURSE (RN) FOUND THAT NASAL CANNULA HAD BECOME DISCONNECTED FROM THE HUMIDIFIER. NO ONE WAS IN THE ROOM WITH THE INFANT; IT HAD APPARENTLY FALLEN OFF OF CONNECTOR. RN RECONNECTED THE NASAL CANNULA TO THE HUMIDIFIER. THERE WERE NO CRACKS IN THE NASAL CANNULA TUBING. NO HARM TO THE PATIENT.
Patient problems: Low Oxygen Saturation
MAUDE report 23600913 ↗InjuryNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS.REFER TO 3004748541-2025-00123 FOR THE FIRST REPORTREFER TO 3004748541-2025-00124 FOR THE SECOND REPORT MED SUN USER FACILITY MDR REPORT -3902560000-2025-8143 REPORTED: WENT TO BEDSIDE FOR MIDNIGHT CARE TIME FOR INFANT. TRACED LINES WITH PRECEPTOR AND FOUND NASAL CANNULA DISCONNECTED FROM HUMIDITY AND ON THE GROUND. CONNECTION CLEANED AND REATTACHED TO HUMIDIFIER. NO INFANT DESATURATION NOTED. I NOTIFIED NICU "[NEONATAL INTENSIVE CARE UNIT]" PROVIDER. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600912 ↗InjuryNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3004748541-2025-00123 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00125 FOR THE THIRD REPORT . MED SUN USER FACILITY MDR REPORT 3902560000-2025-8143 REPORTED: PATIENT'S NASAL CANNULA BECAME DISCONNECTED FROM THE HUMIDIFICATION CONNECTOR, AND THE PATIENT DESATURATED. PATIENT REQUIRED OXYGEN THERAPY TO BRING O2 [OXYGEN] SATS UP. NO HARM TO THE PATIENT.
Patient problems: Low Oxygen Saturation
MAUDE report 23600911 ↗InjuryNov 7, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT A MEDICAL DEVICE INCIDENT (MDI) WITH HARM OR WITH THE POTENTIAL FOR SERIOUS HARM/DEATH HAS BEEN REPORTED. - CARDINAL HEALTH CANADA PRODUCT COMPLAINT (B)(4). UNKNOWN PATIENT ARRIVED VIA EMS IN CRITICAL CONDITION FOLLOWING A SEVERE BURN INJURY. INTERMITTENT SPO2 CHALLENGES INCLUDING DURING INTUBATION WITH MANUAL VENTILATION VIA MASK, AND MANUAL VENTILATION VIA ETT. SPO2 54% AT THE LOWEST. PATIENT REQUIRING CONTINUOUS HIGH FLOW O2 THERAPY (15LPM VIA NON-REBREATHER, FOLLOWED BY CONTINUOUS MANUAL VENTILATION VIA MASK THEN ETT FOR 45 MINUTES, THEN EVENTUALLY 100% ON VENTILATOR, DUE TO PATIENT'S INJURIES. DURING THIS TIME ON 3 OCCASIONS, RRTS NOTICED BAGGER WAS DISCONNECTED FROM O2 TUBING ON THE BAGGER SIDE.
Patient problems: Low Oxygen Saturation
MAUDE report 23501763 ↗InjuryNov 7, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT A MEDICAL DEVICE INCIDENT (MDI) WITH HARM OR WITH THE POTENTIAL FOR SERIOUS HARM/DEATH HAS BEEN REPORTED. - CARDINAL HEALTH CANADA PRODUCT COMPLAINT PCS251008IOELIY . UNKNOWN PATIENT ARRIVED VIA EMS IN CRITICAL CONDITION FOLLOWING A SEVERE BURN INJURY. INTERMITTENT SPO2 CHALLENGES INCLUDING DURING INTUBATION WITH MANUAL VENTILATION VIA MASK, AND MANUAL VENTILATION VIA ETT. SPO2 54% AT THE LOWEST. PATIENT REQUIRING CONTINUOUS HIGH FLOW O2 THERAPY (15LPM VIA NON-REBREATHER, FOLLOWED BY CONTINUOUS MANUAL VENTILATION VIA MASK THEN ETT FOR 45 MINUTES, THEN EVENTUALLY 100% ON VENTILATOR, DUE TO PATIENT'S INJURIES. DURING THIS TIME ON 3 OCCASIONS, RRTS NOTICED BAGGER WAS DISCONNECTED FROM O2 TUBING ON THE BAGGER SIDE. .
Patient problems: Low Oxygen Saturation
MAUDE report 23501762 ↗InjuryNov 7, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT A MEDICAL DEVICE INCIDENT (MDI) WITH HARM OR WITH THE POTENTIAL FOR SERIOUS HARM/DEATH HAS BEEN REPORTED. - CARDINAL HEALTH CANADA PRODUCT COMPLAINT (B)(4). UNKNOWN PATIENT ARRIVED VIA EMS IN CRITICAL CONDITION FOLLOWING A SEVERE BURN INJURY. INTERMITTENT SPO2 CHALLENGES INCLUDING DURING INTUBATION WITH MANUAL VENTILATION VIA MASK, AND MANUAL VENTILATION VIA ETT. SPO2 54% AT THE LOWEST. PATIENT REQUIRING CONTINUOUS HIGH FLOW O2 THERAPY (15LPM VIA NON-REBREATHER, FOLLOWED BY CONTINUOUS MANUAL VENTILATION VIA MASK THEN ETT FOR 45 MINUTES, THEN EVENTUALLY 100% ON VENTILATOR, DUE TO PATIENT'S INJURIES. DURING THIS TIME ON 3 OCCASIONS, RRTS NOTICED BAGGER WAS DISCONNECTED FROM O2 TUBING ON THE BAGGER SIDE.
Patient problems: Low Oxygen Saturation
MAUDE report 23501759 ↗InjuryJul 18, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE PATIENT(S) ACQUIRED PRESSURE INJURY FROM THE NASAL CANNULAS. THERE WAS NO REPORT OF MEDICAL INTERVENTION. SINCE THERE WERE TWO REPORTS OF INJURY A SECONDARY MDR WILL BE SUBMITTED WITH THIS ONE TWO DOCUMENT BOTH INJURIES. THE SECOND MDR IS 1314417-2025-00049.
Patient problems: Pressure Sore/Ulcer
MAUDE report 22549427 ↗MalfunctionJul 18, 2025Connection Problem; Connection Problem
IT WAS REPORTED: LOOSE CONNECTION BETWEEN THE TUBING AND THE EQUIPMENT; IT LITERALLY FALLS OFF WITH THE SLIGHTEST BIT OF MOTION THE MATERIAL FEELS STIFF. NO REPORTED INJURY. WHILE NO HARM OR INJURY WAS REPORTED, ANY COMPONENT THAT IS PART OF THE VENT CIRCUIT (FLEX CONNECTOR, DOUBLE SWIVEL ELBOW, Y-ADAPTER, T-PIECE, ETT ADAPTER, ETC.) BREAKS, CRACKS, OR LEAKS AFTER THE VENT CIRCUIT HAS BEEN ESTABLISHED ON THE PATIENT COULD CAUSE A DELAY IN CARE AND OR LEAD TO A SERIOUS INJURY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22549423 ↗InjuryJul 18, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE PATIENT(S) ACQUIRED PRESSURE INJURY FROM THE NASAL CANNULAS. THERE WAS NO REPORT OF MEDICAL INTERVENTION. SINCE THERE WERE TWO REPORTS OF INJURY A SECONDARY MDR WILL BE SUBMITTED WITH THIS ONE TWO DOCUMENT BOTH INJURIES. THE FIRST MDR IS 1314417-2025-00048.
Patient problems: Pressure Sore/Ulcer
MAUDE report 22549422 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED, THERE WAS A CRACK IN THE CONNECTOR WHILE IT WAS IN USE ON THE PATIENT. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321862 ↗InjuryJun 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE REPORT OF A PATIENT DEVELOPING SORES BEHIND THE EARS AND AROUND THE NOSE AFTER USING THE NASAL FLARED W/U-CONNECT-IT CANNULA IS A REPORTABLE INCIDENT. IT WAS REPORTED THAT THE PATIENT'S SORES WERE BEING TREATED BY THE WOUND AND OSTOMY NURSE, INDICATING THAT MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 22188821 ↗MalfunctionDec 10, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT CALLED FOR ASSISTANCE, EXTREMELY SOB AND WHEEZING. SHE ASKED FOR A MASK TREATMENT, WHICH IS ADMINISTERED VIA NEBULIZER. WRITER ATTEMPTED TO ADMINISTER REQUESTED MEDICATION BUT WAS UNABLE TO DO SO. WRITER CHECKED NEBULIZER COMPONENTS AND ENSURED THAT DIFFUSER WAS LOCKED PROPERLY IN PLACE THEN REATTEMPTED TO ADMINISTER THE MEDICATION. WRITER UNABLE TO GET FLOW METER ABOVE 4L. FLOW METER CHANGED OUT WITH NO POSITIVE RESULT. ENTIRE NEBULIZER SYSTEM CHANGED OUT AND PLUGGED INTO O2 TANK. ADMINISTRATION SUCCESSFUL! FLOW METERS TESTED POST ADMINISTRATION. TESTING CONFIRMED THAT NEBULIZER SET (1ST USED) MALFUNCTIONED AND CHANGE OUT WAS NECESSARY. PCM AND ATTENDING NOTIFIED OF EVENT. MALFUNCTIONING EQUIPMENT SENT DOWN TO PURCHASING WITH PRODUCT COMPLAINT FORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897918 ↗MalfunctionDec 10, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT THEY RETRIEVED AN AIRLIFE VENTURI FACEMASK PACKAGE FROM THE SUPPLY ROOM AND DELIVERED IT TO THE PATIENT'S (PT) ROOM. THE AIRLIFE PACKAGING DID NOT APPEAR TO BE OPEN BUT WAS MISSING THE FACE MASK AND 6-INCH FLEXTUBE. BECAUSE THE PT NEEDED TO BE TRANSPORTED FOR AN EMERGENT CT AND THERE WAS NO TIME TO LOOK FOR A COMPLETE AIRLIFE PACKAGE, A NONREBREATHER WAS USED FOR TRANSPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897774 ↗
Other Vyaire Medical, Inc. products
All Vyaire Medical, Inc. devices →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.
How reports and recalls are matched · Editorial policy · Report an error on this page