N/A 16SOFTTG-25Recalls & reported problems
Salter Labs · Salter Style® Nasal O2 Cannula (Adult), 25' (7.6 m) 0 to 6 LPM, Non DEHP. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411102318), received between Nov 6, 2025 and Apr 22, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
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.
InjuryApr 22, 2026Detachment of Device or Device Component
It was reported that Several of the item were broken. Health deteriorated rapidly because she did not get enough O2. Advice to call in an ambulance but this was not done in the end. Saturation was 70% and the lady was doing very badly.
Patient problems: Low Oxygen Saturation
MAUDE report 24961179 ↗InjuryDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FLEXIBLE TUBING OF THE NASAL CANNULA DETACHED FROM THE NASAL TIP ON ONE SIDE ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23891301 ↗InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT INABILITY TO REMOVE THREAD GRIP ADAPTER CAUSING THE O2 TUBING TO DETACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493537 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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