O2 Cannula 001350Recalls & reported problems
Salter Labs · U/Connect-it Oxygen Tubing 7 feet (2.1m) Crush Resistant Oxygen Tubing, Vynil Tipped · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Salter Labs oxygen tubing delivers oxygen to patients through a flexible, crush-resistant line. The reports mostly describe the tubing twisting or kinking and the connections not fitting securely, so the line came loose or disconnected during use, sometimes going along with low oxygen levels. There are 87 reports, with no deaths and 14 injuries. No recalls name this device. Reports have climbed notably, from 31 in the prior 12 months to 56 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10889483570111), received between May 9, 2025 and Sep 29, 2026 — classified as 15 injuries, 78 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (34 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent34
- Loose or Intermittent Connection20
- Connection Problem17
- Incomplete or Inadequate Connection10
- Disconnection4
- Fitting Problem4
- Gas/Air Leak3
- Material Deformation3
Patient problems
- Low Oxygen Saturation36
- No Clinical Signs, Symptoms or Conditions35
- Insufficient Information20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Bradycardia1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Disconnection
Patient problems: Bradycardia; Low Oxygen Saturation
MAUDE report 50940898 ↗MalfunctionSep 8, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50676589 ↗MalfunctionSep 8, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676588 ↗MalfunctionSep 8, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50676587 ↗MalfunctionAug 25, 2026Loose or Intermittent Connection
Patient problems: Low Oxygen Saturation
MAUDE report 50441425 ↗MalfunctionAug 25, 2026Loose or Intermittent Connection
Patient problems: Insufficient Information
MAUDE report 50441424 ↗MalfunctionAug 25, 2026Loose or Intermittent Connection
Patient problems: Insufficient Information
MAUDE report 50441423 ↗MalfunctionAug 25, 2026Loose or Intermittent Connection
Patient problems: Insufficient Information
MAUDE report 50441422 ↗MalfunctionAug 4, 2026Material Twisted/Bent
Patient problems: Insufficient Information; Low Oxygen Saturation
MAUDE report 50132440 ↗MalfunctionJun 25, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT ON (B)(6) 2026 THE OXYGEN (O2) CONNECTION WAS TESTED ON THE PORTABLE OXYGEN UNIT, AND THE CONNECTION WAS FOUND TO BE LOOSE AND COULD BE DISCONNECTED EASILY. THIS OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 25630089 ↗MalfunctionJun 25, 2026Incomplete or Inadequate Connection
IT WAS REPORTED, THE OXYGEN (O2) TUBING PROVIDED WITH THE BAGGER DID NOT CONNECT SECURELY AND REPEATEDLY DISCONNECTED WHILE BAGGING THE PATIENT. IT WAS ADDITIONALLY REPORTED, WHEN ATTEMPTING TO APPLY ADDITIONAL PRESSURE TO CONNECT THE TUBING, THE BAGGER COMPONENTS COLLAPSED, WHICH REQUIRED THE STAFF TO OBTAIN A NEW BAGGER AND REASSEMBLE THE PARTS, WHICH DELAYED PATIENT CARE. THERE WAS NO REPORT OF HARM INJURY TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627990 ↗MalfunctionJun 4, 2026Incomplete or Inadequate Connection
IT WAS REPORTED, THE OXYGEN (O2) TUBING PROVIDED WITH THE BAGGER DID NOT CONNECT SECURELY AND REPEATEDLY DISCONNECTED WHILE BAGGING THE PATIENT. THERE WAS NO REPORT OF HARM INJURY TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402277 ↗MalfunctionJun 4, 2026Incomplete or Inadequate Connection
IT WAS REPORTED, THE OXYGEN (O2) TUBING PROVIDED WITH THE BAGGER DID NOT CONNECT SECURELY AND REPEATEDLY DISCONNECTED WHILE BAGGING THE PATIENT. THERE WAS NO REPORT OF HARM INJURY TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402249 ↗MalfunctionJun 4, 2026Incomplete or Inadequate Connection
IT WAS REPORTED, THE OXYGEN (O2) TUBING PROVIDED WITH THE BAGGER DID NOT CONNECT SECURELY AND REPEATEDLY DISCONNECTED WHILE BAGGING THE PATIENT. THERE WAS NO REPORT OF HARM INJURY TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25401346 ↗MalfunctionJun 4, 2026Incomplete or Inadequate Connection
IT WAS REPORTED, THE OXYGEN (O2) TUBING PROVIDED WITH THE BAGGER DID NOT CONNECT SECURELY AND REPEATEDLY DISCONNECTED WHILE BAGGING THE PATIENT. THERE WAS NO REPORT OF HARM INJURY TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25401058 ↗MalfunctionJun 4, 2026Incomplete or Inadequate Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2026-00101 FOR THE FIRST REPORT IT WAS REPORTED, THE OXYGEN (O2) TUBING PROVIDED WITH THE BAGGER DID NOT CONNECT SECURELY AND REPEATEDLY DISCONNECTED WHILE BAGGING THE PATIENT. THERE WAS NO REPORT OF HARM INJURY TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400830 ↗MalfunctionJun 4, 2026Incomplete or Inadequate Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2026-00102 FOR THE SECOND REPORT IT WAS REPORTED ON (B)(6) 2025 DURING AN OXYGEN (O2) DELIVERY PROCEDURE, THE PATIENT DESATURATED; THE EVENT CREATED A HIGHLY STRESSFUL SITUATION FOR THE STAFF WHO WAS ATTEMPTING TO TROUBLESHOOT THE BAGGER. IT WAS ADDITIONALLY REPORTED, THAT THERE WERE NO CONSEQUENCES [FOR] THE PATIENT.
Patient problems: Low Oxygen Saturation
MAUDE report 25400829 ↗InjuryMay 29, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT SPO2 IN LOW 80'S AND NOT RECOVERING. BEDSIDE NURSE INCREASED OXYGEN, BUT SPO2 STILL BORDERLINE. WRITER TO BEDSIDE AND SPO2 PROBE CHANGED. O2 TUBING NOTED TO BE 75% COLLAPSED WITH POOR AIRFLOW TO HIGH FLOW NASAL CANNULA. TUBING CHANGED AND SECURED TO PREVENT COLLAPSE, BUT EVEN WITH NEW PACKAGE, TUBING PRONE TO COLLAPSING. AFTER THIS ADJUSTMENT, ABLE TO WEAN SUPPORT. THE MAIN ISSUE IS THAT TUBING IS INSTALLED AND SECURED BUT SEEMS TO SLOWLY COMPRESS ITSELF WITH THE PULL OF GRAVITY. THERE ARE NO ALARMS TO ALERT ANYONE TO THIS, SO IT CAN BE A SILENT HAZARD THAT HAPPENS AND CAN EASILY GO UNNOTICED".
Patient problems: Low Oxygen Saturation
MAUDE report 25340966 ↗MalfunctionMay 29, 2026Material Twisted/Bent
IT WAS REPORTED, THE NURSE WAS CALLED TO THE PATIENT'S BEDSIDE, DUE TO PATIENT DESATURATING ON 2L (21%), [OXYGEN (O2)] WAS INCREASED TO 30%; HOWEVER, [PATIENT'S OXYGEN SATURATION] STILL DID NOT COME UP VERY WELL. THE PATIENT WAS ASSESSED AT BEDSIDE AND WAS FOUND TO BE BREATHING APPROPRIATELY, 'NO WORK OF BREATHING.' THE PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) PROBE [WAS] CHANGED, STILL DID NOT IMPROVE. THE HIGH FLOW EQUIPMENT WAS ASSESSED, AND IT WAS NOTED THAT THE OXYGEN TUBING CONNECTING FROM THE HUMIDIFIER POT TO THE FLOW METER WAS KINKED AT THE HUMIDIFIER POT, THUS CUTTING OFF ALL RESPIRATORY SUPPORT. THE O2 TUBING WAS REPOSITIONED AND THE PATIENT'S SPO2 INCREASED BACK TO TARGET LEVELS (>90%). NO ADDITIONAL INFORMATION PROVIDED CONCERNING PATIENT OUTCOME PROVIDED.
Patient problems: Low Oxygen Saturation
MAUDE report 25340354 ↗MalfunctionApr 17, 2026Material Too Rigid or Stiff
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3004748541-2026-00077 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00078 FOR THE SECOND REPORT . REFER TO 3004748541-2026-00079 FOR THE THIRD REPORT . IT WAS REPORTED: THE TUBING WAS VERY DIFFICULT TO USE DUE TO EXCESSIVE STIFFNESS AND RESULTED IN A LOSS OF TIME IN URGENT SITUATIONS. NO INFORMATION PROVIDED CONCERNING PATIENT OUTCOMES; THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 24918196 ↗MalfunctionApr 17, 2026Connection Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3004748541-2026-00077 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00079 FOR THE THIRD REPORT. REFER TO 3004748541-2026-00080 FOR THE FOURTH REPORT. IT WAS REPORTED: DISCONNECTIONS BETWEEN EXTENSION CORDS COMPROMISED OXYGEN THERAPY AND REQUIRED THE USE OF A PLASTIC ADAPTER TO SECURE THE EXTENSION CORD CIRCUIT. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 24917984 ↗MalfunctionApr 17, 2026Connection Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3004748541-2026-00078 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00079 FOR THE THIRD REPORT. REFER TO 3004748541-2026-00080 FOR THE FOURTH REPORT. IT WAS REPORTED: THE TUBING WAS EXTREMELY DIFFICULT TO CONNECT TO THE NEBULIZER; BOTH ENDS WERE PROBLEMATIC AND DISCONNECTED DURING TREATMENT WHICH COMPROMISED THE AMOUNT OF MEDICATION ADMINISTERED AND LENGTHENED THE TIME REQUIRED TO NEBULIZE AND ADMINISTER MEDICATION. NO INFORMATION PROVIDED CONCERNING PATIENT OUTCOMES; THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 24917983 ↗MalfunctionApr 17, 2026Connection Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3004748541-2026-00077 FOR THE FIRST REPORT, REFER TO 3004748541-2026-00078 FOR THE SECOND REPORT , REFER TO 3004748541-2026-00080 FOR THE FOURTH REPORT . IT WAS REPORTED: FREQUENT DISCONNECTIONS FROM THE NASAL CANNULA OCCURRED BETWEEN THE EXTENSION CORDS AND COMPROMISED THE QUALITY OF OXYGEN THERAPY PROVIDED. NO INFORMATION PROVIDED CONCERNING PATIENT OUTCOMES; THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 24917982 ↗MalfunctionApr 17, 2026Material Deformation
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 3004748541-2026-00074 FOR THE FIRST REPORT REFER TO 3004748541-2026-00075 FOR THE SECOND REPORT. IT WAS REPORTED, THE KINKED TUBING LIMITED THE OXYGEN FLOW TO THE PATIENT; THE TUBING WAS CHANGED. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT. NO ADDITIONAL INFORMATION PROVIDED CONCERNING PATIENT OUTCOME.
Patient problems: Low Oxygen Saturation
MAUDE report 24916788 ↗MalfunctionApr 17, 2026Material Deformation
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 3004748541-2026-00074 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00076 FOR THE THIRD REPORT . IT WAS REPORTED, THE KINKED TUBING LIMITED THE OXYGEN FLOW TO THE PATIENT; THE TUBING WAS CHANGED. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT. NO ADDITIONAL INFORMATION PROVIDED CONCERNING PATIENT OUTCOME.
Patient problems: Low Oxygen Saturation
MAUDE report 24916787 ↗
Other Tubing, Pressure And Accessories devices
- AirLife 2002-7Salter Labs · TUBING, PRESSURE AND ACCESSORIES6 reports
- AirLife SO-1968-0Salter Labs · TUBING, PRESSURE AND ACCESSORIES3 reports
- O2 Tubing 001304USalter Labs · Tubing, Pressure And Accessories3 reports
- AirLife SO-1188-0Salter Labs · TUBING, PRESSURE AND ACCESSORIES3 reports
- AirLife 2025G-25Salter Labs · TUBING, PRESSURE AND ACCESSORIES2 reports
- Medline HCS4550GBMedline Industries, Inc. · TUBING, PRESSURE AND ACCESSORIES2 reports
- Flow sensor 155500Hamilton Medical AG · Tubing, Pressure And Accessories2 reports
- HUDSON RCI HUD1115Medline Industries, Inc. · TUBING, PRESSURE AND ACCESSORIES2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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