Comfort Soft Plus 0567-RCRecalls & reported problems
Salter Labs · Comfort Soft Plus Adult Cannula · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889483233993), received between Sep 16, 2025 and Dec 15, 2025 — classified as 3 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. 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
- Loose or Intermittent Connection2
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED: THE TUBING SLIPPED OUT OF THE NASAL PRONG PORTION OF THE TUBING AND WAS UNABLE TO REMAIN SECURELY ATTACHED; THE OXYGEN (O2) TUBING WAS REPLACED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811866 ↗MalfunctionNov 20, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED: TUBING BECAME DISCONNECTED AT CONNECTION SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23612387 ↗MalfunctionSep 16, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED: THE TUBING SLIPPED OUT OF THE NASAL PRONG PORTION OF THE TUBING AND WAS UNABLE TO REMAIN SECURELY ATTACHED; THE OXYGEN (O2) TUBING WAS REPLACED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069768 ↗
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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