O2 Cannula SFT2601Recalls & reported problems
Salter Labs · Infant Cushion Nasal Cannula 7 foot (2.1m) Crush-Resistant Oxygen Tubing · Class 1
- 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 10889483605714), received between Sep 29, 2025 and Sep 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SECOND DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00069 FOR THE FIRST REPORT. IT WAS REPORTED- A PATIENT REQUIRED CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AFTER A DESATURATION EPISODE DUE TO THE TUBING 'SLIPPING' OFF FOR AN UNDETERMINED AMOUNT OF TIME. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION OR IF ANY MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 23175375 ↗MalfunctionSep 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SECOND DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00070 FOR THE SECOND REPORT. IT WAS REPORTED, AN UNSPECIFIED PATIENT SAFETY EVENT OCCURRED DUE TO THE TUBING NOT ATTACHING SECURELY TO THE HUMIDIFIER BOTTLE AND SLIPPING OFF. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION OR IF ANY MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 23175374 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.