Airlife™ Sterile Water for Inhalation, USP, 500 ml 002620 (UDI 10190752141643)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10190752141643), received between Nov 21, 2022 and Dec 19, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (3 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING USE, THE HOSPITAL STAFF NOTICED THAT THE 002620 - HUMIDIFIER KIT 500ML 12/CS WAS EASILY DISENGAGED FROM THE OXYGEN GAUGE. THEY ALSO OBSERVED THAT IT CONSTANTLY ALARMS, AND THE PRESSURE IS BUILDING UP INSIDE THE BOTTLE, WHICH CAUSES IT TO EXPAND OR BLOAT. UPON INSPECTION, THEY NOTICED THAT THE OXYGEN PORT OPENING WAS TOO SMALL.THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361414 ↗
• MalfunctionDec 19, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING USE, THE HOSPITAL STAFF NOTICED THAT THE (B)(6) - HUMIDIFIER KIT 500ML 12/CS WAS EASILY DISENGAGED FROM THE OXYGEN GAUGE. THEY ALSO OBSERVED THAT IT CONSTANTLY ALARMS, AND THE PRESSURE IS BUILDING UP INSIDE THE BOTTLE, WHICH CAUSES IT TO EXPAND OR BLOAT. UPON INSPECTION, THEY NOTICED THAT THE OXYGEN PORT OPENING WAS TOO SMALL. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361408 ↗
• MalfunctionDec 19, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING USE, THE HOSPITAL STAFF NOTICED THAT THE 002620 - HUMIDIFIER KIT 500ML 12/CS WAS EASILY DISENGAGED FROM THE OXYGEN GAUGE. THEY ALSO OBSERVED THAT IT CONSTANTLY ALARMS, AND THE PRESSURE IS BUILDING UP INSIDE THE BOTTLE, WHICH CAUSES IT TO EXPAND OR BLOAT. UPON INSPECTION, THEY NOTICED THAT THE OXYGEN PORT OPENING WAS TOO SMALL. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361355 ↗
• InjuryDec 19, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 2620 HUMIDIFIER KIT 500ML 12/CS IS PRODUCING 0 AIR SOUND FROM THE CANNULA EVEN WHEN IT IS ON 4 LITERS DURING PATIENT USE. THE PATIENTS SATURATION DIPPED BELOW 60. THE NURSE DISCONNECTED THE OXYGEN TUBING FROM THE HUMIDIFIER AND REPLACED THE HUMIDIFIER WITH A NEW ONE AND THE PATIENTS SATURATION INCREASED TO 78. THEY WERE ABLE TO WEAN 02 BACK DOWN TO 2L. THEY OBSERVED A LARGE CRACK IN THE PLASTIC WHERE OXYGEN MUST HAVE BEEN LEAKING OUT. FURTHERMORE, THERE WAS NO HARM ON THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18360734 ↗
• MalfunctionNov 15, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002620 - HUMIDIFIER KIT 500ML 12/CS WAS SO FULL THAT BUBBLES BACKED UP TO THE TUBING AND WATER BACKED UP IN THE CANNULA. ALSO, THE TUBING FOR OXYGEN WAS BEING FILLED WITH WATER, AND WATER DRIPS INTO THE NOSE OF THE PATIENT AND INTO THE CANNULA. THE PATIENT'S STATUS IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145419 ↗
• MalfunctionOct 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NOZZLE WHERE THE NASAL CANNULA IS PLACED DOES NOT HAVE A HOLE TO ALLOW OXYGEN TO COME OUT, SO PRESSURE BUILDS UP IN THE 002620 - HUMIDIFIER KIT 500ML 12/CS AND WATER COMES OUT OF THE CONNECTOR ON TOP. THE SAID ISSUE OCCURRED DURING USE ON A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17880115 ↗
• MalfunctionJun 14, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHEN THE BOTTLE OF HUMIDIFIER KIT 500ML 12/CS IS OPENED ON THE FRONT WITH A TWIST TAB, IT DOESN¿T ALWAYS COMPLETELY OPEN, AND SOMETIMES ISN¿T OBVIOUS WHEN IT'S HOOKED UP TO FLOW ON THE WALL. WHEN IT'S HOOKED UP AND TURNED ON, FLOW DOESN¿T COME OUT THE FRONT VERY WELL. THE CUSTOMER TRIED TO OPEN THE HOLE WITH A SCISSOR AND REMOVE IT FROM THE WALL, CAUSING A WATER FOUNTAIN OF BACK PRESSURE TO SPRAY ALL OVER THE STAFF MEMBER AND THE ROOM. THIS HAPPENS OCCASIONALLY AND NOT WITH ALL BOTTLES. ALSO, THE CUSTOMER IS UNABLE TO PUT MORE THAN 3 LITERS OF FLOW THROUGH THE SYSTEM BECAUSE IT POPS OFF AND WHEN DISCONNECTED, CAUSES THE FOUNTAIN TO OCCUR AND SPRAYS ALL OVER THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126507 ↗
• MalfunctionFeb 8, 2023Smoking; Obstruction of Flow; Sparking; Smoking; Obstruction of Flow; Sparking

  IT WAS REPORTED TO VYAIRE MEDICAL THAT VYAIRE HUMIDIFIER WAS FOUND ON A PATIENT WITH WATER CASCADING FROM THE FLOWMETER SCREW TOP. THE NOZZLE THAT THE CANNULA TUBING ATTACHES TO IS OCCLUDED. AFTER THE REMOVAL OF THE "SNAP OFF" PLASTIC TUBE THE WATER CAUSED AN ELECTRICAL CORD TO SINGE, SPARK AND SMOKE. UPON EXAMINING THE "NOZZLE" IT IS OCCLUDED AND AIR CANNOT PASS THROUGH IT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328975 ↗
• MalfunctionNov 21, 2022Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THE HUMIDIFIER KIT 500ML 12/CS STERILE WATER INHALATION WAS NOT BUBBLING PROPERLY DURING PATIENT USE, AND STARTED TO SPOUT STERILE WATER FROM THE TOP DUE TO INCREASE PRESSURE. THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838067 ↗