N/A 16SOFT-7Recalls & reported problems
Salter Labs · Salter Style Nasal O2 Cannula (Adult), 7' (2.1 m) 0 to 6 LPM, Non DEHP. · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607411915772), received between May 23, 2022 and Nov 13, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility2
- Device Emits Odor1
- Device Ingredient or Reagent Problem1
- Gas/Air Leak1
Patient problems
- Rash2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burning Sensation1
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE NASAL CANNULA HAD LEAKS; THE PATIENT HAS A NEW CANNULA. THERE WERE NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550862 ↗InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT'S SKIN BROKE OUT INTO A RASH WHEN USING THE CANNULA. IT WAS ADDITIONALLY REPORTED, MEDICAL ATTENTION WAS SOUGHT. NO INFORMATION PROVIDED CONCERNING THE TYPE OF TREATMENT/THERAPY (IF ANY) THAT WAS PROVIDED.
Patient problems: Rash
MAUDE report 23444227 ↗InjuryJun 23, 2022Patient-Device Incompatibility
CUSTOMER IS ALLERGIC TO CANNULA. CANNULA HAS BURNED CUSTOMERS FACE, EYE BROWS, BACK OF NECK AND EARS.
Patient problems: Hypersensitivity/Allergic reaction; Superficial (First Degree) Burn
MAUDE report 14793376 ↗MalfunctionJun 17, 2022Device Ingredient or Reagent Problem
OSE PIECE IS COLORED AND PATIENT IS GETTING A BURNING SENSATION AND RASH. PATIENT IS GETTING A BURNING SENSATION ON HER NOSE AND GOT A REALLY BAD RASH ON HER NOSE AND TOP LIP.
Patient problems: Burning Sensation; Rash
MAUDE report 14737112 ↗InjuryMay 23, 2022Device Emits Odor
ITEMS HAD OVERPOWERING SMELL OF CIGARETTE SMOKE, MADE SICK TO USE. ALL OF LOT NUMBER I HAVE ARE THE SAME. SALTER LABS CANNULAS PART # 16SOFT-7, LOT #(10)210802E. NO TESTS. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14488509 ↗
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.