n.a. 8575GNRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551251805), received between Sep 2, 2025 and Apr 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Fragmentation; Physical Resistance/Sticking

  IT WAS REPORTED THAT "LARYNGOSCOPE HOLDER WAS STUCK AND NOT ABLE TO ROTATE TO THE FULL ANGULATION WHEN PRESSURE IS APPLIED. SOME TINY METAL FRAGMENTS WERE ALSO FOUND ON THE GEAR. THE DEFECT WAS NOTED AFTER REPROCESSING PROCEDURE AND NOT INVOLVING MEDICAL PROCEDURE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027807 ↗
• MalfunctionSep 16, 2025Circuit Failure; Mechanical Jam; Physical Resistance/Sticking; Circuit Failure; Mechanical Jam; Physical Resistance/Sticking

  "IT WAS REPORTED THAT THE ADJUSTMENT WHEEL ON 8575GN LEWY LARYNGOSCOPE HOLDER WAS STUCK AND NOT ABLE TO ROTATE TO THE FULL ANGULATION WHEN THE CHEST SUPPORT WAS PLACED DURING PROCEDURE. SOME TINY METAL FRAGMENTS WERE FOUND ON THE GEAR BUT DID NOT FELL INTO PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066696 ↗
• MalfunctionSep 16, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  "IT WAS REPORTED THAT THE ADJUSTMENT WHEEL ON 8575GN LEWY LARYNGOSCOPE HOLDER WAS STUCK AND NOT ABLE TO ROTATE TO THE FULL ANGULATION WHEN THE CHEST SUPPORT WAS PLACED DURING PROCEDURE. SOME TINY METAL FRAGMENTS WERE FOUND ON THE GEAR BUT DID NOT FELL INTO PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066561 ↗
• MalfunctionSep 2, 2025Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT "THE ADJUSTMENT WHEEL ON THE LARYNGOSCOPE HOLDER WAS STUCK AND NOT ABLE TO ROTATE TO THE FULL ANGULATION WHEN THE CHEST SUPPORT WAS PLACED DURING PROCEDURE. SOME TINY METAL FRAGMENTS WERE FOUND ON THE GEAR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937350 ↗