Shiley 86236 (UDI 10884521619920)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521619920), received between Sep 5, 2019 and Feb 28, 2024 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Defective Component” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SIX DIFFERENT ENDOTRACHEAL TUBES WITH UNIDENTIFIED AFFECTED QUANTITY HAD A GENERAL COMPLAINT ABOUT QUALITY AND TEXTURE THAT CAUSED TRAUMA TO THE NASAL PASSAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18803448 ↗
• InjuryFeb 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SIX DIFFERENT ENDOTRACHEAL TUBES WITH UNIDENTIFIED AFFECTED QUANTITY HAD A GENERAL COMPLAINT ABOUT QUALITY AND TEXTURE THAT CAUSED TRAUMA TO THE NASAL PASSAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18803405 ↗
• InjuryFeb 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SIX DIFFERENT ENDOTRACHEAL TUBES WITH UNIDENTIFIED AFFECTED QUANTITY HAD A GENERAL COMPLAINT ABOUT QUALITY AND TEXTURE THAT CAUSED TRAUMA TO THE NASAL PASSAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18803348 ↗
• MalfunctionJan 20, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A STICKY RESIDUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11200887 ↗
• MalfunctionFeb 25, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USED, THE DEVICE CUFF DEHP MATERIAL CAUSED GLOTTIS SWELLING.

  Patient problems: Swelling

  MAUDE report 9750423 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970420 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970414 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970366 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970322 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970278 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970251 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970234 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970209 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970192 ↗
• MalfunctionSep 6, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970077 ↗
• MalfunctionSep 5, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8968110 ↗