Comfort Soft Plus 0556Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483228869), received between Apr 21, 2026 and Apr 21, 2026 — 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Loose or Intermittent Connection

  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. REFER TO 3004748541-2026-00084 FOR THE SECOND REPORT PATIENT (B)(6) - WHEN THE CARE PROVIDER WENT TO THE PATIENT'S ROOM IT WAS NOTICED THE CLEAR TRANSPARENT TUBE, ON THE COMFORT SOFT PLUS CANNULA, WAS FOUND DISCONNECTED FROM THE GREEN TUBE. NO ADDITIONAL INFORMATION PROVIDED CONCERNING PATIENT AFFECT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24940918 ↗
• MalfunctionApr 21, 2026Loose or Intermittent Connection

  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 3004748541-2026-00083 FOR THE FIRST REPORT. PATIENT (B)(6) - IT WAS REPORTED WHEN THE PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) DROPPED DOWN TO THE 50S ON THE MONITOR, ON THE COMFORT SOFT PLUS CANNULA, IT WAS NOTICED THE CLEAR TRANSPARENT TUBE WAS DISCONNECTED.

  Patient problems: Insufficient Information

  MAUDE report 24940917 ↗