NA 8404AXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551441855), received between May 27, 2025 and Sep 30, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954106 ↗
• MalfunctionSep 9, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699291 ↗
• MalfunctionAug 19, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328241 ↗
• MalfunctionJul 9, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763300 ↗
• MalfunctionJun 8, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT LOW LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436388 ↗
• MalfunctionApr 29, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT LOW LIGHT FROM LED-LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033714 ↗
• MalfunctionFeb 25, 2026Device Reprocessing Problem; Optical Problem

  IT WAS REPORTED THAT THERE IS LOW LIGHT FROM THE DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449706 ↗
• MalfunctionDec 19, 2025Device Reprocessing Problem; Output below Specifications; Device Reprocessing Problem; Output below Specifications

  IT WAS REPORTED THAT THERE IS DIM LIGHT SOURCE. NO PROCEDURE OR PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852422 ↗
• MalfunctionDec 17, 2025Device Reprocessing Problem; Energy Output Problem; Device Reprocessing Problem; Energy Output Problem

  IT WAS REPORTED THAT LIGHT SOURCE DEFECTIVE. ACCORDING TO THE EVENT DESCRIPTION THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832915 ↗
• MalfunctionOct 31, 2025Optical Problem; Poor Quality Image; Optical Problem

  IT WAS REPORTED "LOW LIGHT FROM THIS BLADE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437928 ↗
• MalfunctionJul 31, 2025Device Reprocessing Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Device Reprocessing Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE C-MAC POCKET MONITOR DURING INTUBATION. NO FURTHER INFORMATION AVAILABLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22682569 ↗
• MalfunctionJul 10, 2025Device Reprocessing Problem; No Display/Image; Poor Quality Image; Device Reprocessing Problem; No Display/Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS "LOW LIGHT FROM LED, DARK PICTURE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472398 ↗
• MalfunctionMay 27, 2025Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  ACCORDING TO THE INFORMATION RECEIVED, LED OF THE VIDEO LARYNGOSCOPE TOO DARK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092472 ↗
• MalfunctionMay 27, 2025Device Reprocessing Problem; Electrical /Electronic Property Problem; Optical Problem; Device Reprocessing Problem; Electrical /Electronic Property Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, THERE IS NO LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087993 ↗