O2 Cannula SFT2699Recalls & reported problems
Salter Labs · Adult Cushion Nasal Cannula With 7 foot (2.1 m) Crush-Resistant Oxygen Tubing and U/Connect-It Adapter · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483605837), received between Aug 22, 2025 and Aug 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 Puncture/Hole2
Patient problems
- Discomfort2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Material Puncture/Hole; Material Puncture/Hole
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 3004748541-2025-00050 FOR THE FIRST REPORT IT WAS REPORTED: WHEN USED BY THE PATIENT THEY COMPLAINED OF [A GENERAL] DISCOMFORT. A PINHOLE WAS FOUND IN THE MIDDLE OF THE TWO PRONGS; THERE WAS NO REPORTED INJURY.
Patient problems: Discomfort
MAUDE report 22879652 ↗MalfunctionAug 22, 2025Material Puncture/Hole; Material Puncture/Hole
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. IT WAS REPORTED: WHEN USED BY THE PATIENT THEY COMPLAINED OF [A GENERAL] DISCOMFORT. A PINHOLE WAS FOUND IN THE MIDDLE OF THE TWO PRONGS; THERE WAS NO REPORTED INJURY.
Patient problems: Discomfort
MAUDE report 22879644 ↗
Other Cannula, Nasal, Oxygen devices
- Fisher & Paykel Healthcare OPT844Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen39 reports
- Fisher and Paykel Healthcare OPT312Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 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.
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