Comfort Soft Plus 0568Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483228982), received between Jul 25, 2025 and Jul 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionJul 25, 2025Material Twisted/Bent; Material Twisted/Bent

  (B)(4) 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 3004748541-2025-00038 FOR THE FIRST REPORT. IT WAS REPORTED, THE OXYGEN (O2) TUBING WAS BENT AT WATER BOTTLE, IT HAD TO BE REPLACED DUE TO THE PATIENT NOT GETTING O2; THE THERAPIST SAID THE TUBING IS A LOT THINNER. THE DEVICE WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615792 ↗
• MalfunctionJul 25, 2025Material Twisted/Bent; Material Twisted/Bent

  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 3004748541-2025-00039 FOR THE SECOND REPORT IT WAS REPORTED, THE OXYGEN (O2) TUBING WAS BENT AT WATER BOTTLE, IT HAD TO BE REPLACED DUE TO THE PATIENT NOT GETTING O2; THE THERAPIST SAID THE TUBING IS A LOT THINNER. THE DEVICE WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22614804 ↗