O2 Tubing 001304URecalls & reported problems
Salter Labs · Oxygen Tubing 21 feet (6.4m) Crush Resistant Oxygen Tubing, Vynil Tipped and U/Connect-It Adapter · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889483569863), received between May 21, 2025 and Jul 10, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED, THE REPLACEMENT OXYGEN TUBING BECAME KINKED DURING THE PROCEDURE AND CUT OFF THE PATIENT'S OXYGEN SUPPLY; THE PATIENT DE-SATURATED AND REQUIRED BAGGING. THE PATIENT RECOVERED. IT WAS ADDITIONALLY REPORTED, AFTER THE PROCEDURE ENDED, THE TUBING WAS DISCOVERED TO BE KINKED AT THE OXYGEN REGULATOR AND THROUGHOUT TUBING.
Patient problems: Low Oxygen Saturation
MAUDE report 22470790 ↗MalfunctionMay 21, 2025Material Twisted/Bent; Material Twisted/Bent
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 1314417-2025-00030 FOR THE SECOND REPORT. AN ISSUE WITH THE TUBE KINKING OCCURRED, WHICH RESULTED IN THE PATIENT, WHO WAS UNDER SEDATION, NOT RECEIVING THE FULL AMOUNT OF LITERS PER MINUTE OF OXYGEN. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066701 ↗MalfunctionMay 21, 2025Material Twisted/Bent; Material Twisted/Bent
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 1314417-2025-00029 FOR THE FIRST REPORT. AN ISSUE WITH THE TUBE KINKING OCCURRED, WHICH RESULTED IN THE PATIENT, WHO WAS UNDER SEDATION, NOT RECEIVING THE FULL AMOUNT OF LITERS PER MINUTE OF OXYGEN. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065782 ↗
Other Tubing, Pressure And Accessories devices
- O2 Cannula 001350Salter Labs · Tubing, Pressure And Accessories93 reports
- AirLife 2002-7Salter Labs · TUBING, PRESSURE AND ACCESSORIES6 reports
- AirLife SO-1968-0Salter Labs · TUBING, PRESSURE AND ACCESSORIES3 reports
- AirLife SO-1188-0Salter Labs · TUBING, PRESSURE AND ACCESSORIES3 reports
- Flow sensor 155500Hamilton Medical AG · Tubing, Pressure And Accessories2 reports
- AirLife 2025G-25Salter Labs · TUBING, PRESSURE AND ACCESSORIES2 reports
- HUDSON RCI HUD1115Medline Industries, Inc. · TUBING, PRESSURE AND ACCESSORIES2 reports
- Medline HCS4550GBMedline 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page