Medline CPRM4416Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277700482), received between Sep 12, 2026 and Sep 18, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fitting Problem; Material Deformation

  It was reported that "Trying to attach the mask to the bag and could not because the connector was misshapen and would not fit. The connector is hard plastic and could not be manipulated".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818160 ↗
• MalfunctionSep 16, 2026Inadequate Filtration Process

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786943 ↗
• MalfunctionSep 12, 2026Disconnection

  Patient problems: Low Oxygen Saturation

  MAUDE report 50744783 ↗