Shiley 86235 (UDI 10884521797277)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521797277), received between Mar 23, 2022 and Dec 1, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Disconnection; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Disconnection; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS DEFECTIVE PRIOR TO USE. BASED ON THE ATTACHED PHOTO THE CONNECTOR WAS DISCONNECTED FROM THE TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680073 ↗
• MalfunctionJul 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE TRACHEAL TUBE, IT WAS FOUND THAT THE TRACHEAL TUBE JOINT WAS SEPARATED FROM THE TUBE. IMMEDIATELY REPLACED IT WITH THE NEW TRACHEAL TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395616 ↗
• MalfunctionJun 26, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT NUMBERS AND MARKINGS WERE WEARING OFF ON ENDOTRACHEAL TUBE, RESULTING IN THE LABEL BECOMING ILLEGIBLE. THIS CAU SED STAFF TO BE UNABLE TO SEE WHERE THE TUBE WAS TAPED, LEADING TO DIFFICULTY IN PROPERLY ADVANCING AND RE-SECURING THE TUBE. AS A RESULT, THE PATIENT WAS REQUIRED TO BE REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 22333866 ↗
• MalfunctionJun 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT NUMBERS AND MARKINGS WERE WEARING OFF ON ENDOTRACHEAL TUBE, RESULTING IN THE LABEL BECOMING ILLEGIBLE. THIS CAUSED STAFF TO BE UNABLE TO SEE WHERE THE TUBE WAS TAPED, LEADING TO DIFFICULTY IN PROPERLY ADVANCING AND RE-SECURING THE TUBE. AS A RESULT, THE PATIENT WAS REQUIRED TO BE REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 22290692 ↗
• MalfunctionJun 9, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A 3.5MM ENDOTRACHEAL TUBE WAS DISCOVERED TO BE DEFECTIVE PRIOR TO USE. THE TUBE WAS OBSERVED TO BE SEALED INTO THE EDGE OF THE PACKAGING, AND THE END OF THE TUBE WAS MELTED. THE DEFECT WAS IDENTIFIED BEFORE THE DEVICE REACHED THE PATIENT, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171126 ↗
• MalfunctionMay 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE VENTILATOR SHOWED OBVIOUS AIR LEAKAGE. THE TUBE WAS REPLACED IN TIME.

  Patient problems: Unintended Extubation

  MAUDE report 22070924 ↗
• MalfunctionNov 18, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, DURING PREPARATION, THE ENDOTRACHEAL TUBE'S SCALE MARKINGS DISSIPATED WHILE OPENING FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705586 ↗
• InjuryAug 9, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, DURING USE, THE MARKING OF THE ENDOTRACHEAL TUBE ON THE LIP WAS WORN OFF AND UNABLE TO BE READ. BASED ON THE REPORT, THE PATIENT WAS EXTUBATED AND NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951703 ↗
• MalfunctionJul 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722406 ↗
• MalfunctionJul 10, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S PILOT LINE WAS CRACKED, AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712914 ↗
• MalfunctionApr 13, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE NUMBERS OR MARKING HAD WORN OFF, EVEN ABOVE WHERE THE ENDOTRACHEAL TUBE WAS TAPED DURING USE AND CAUSED UNPLANNED SELF-EXTUBATION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19102634 ↗
• MalfunctionDec 18, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S MARKINGS WORE OFF DURING USE. THE TUBE WAS ELECTIVELY EXCHANGED FOR A BRONCHO TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18348452 ↗
• MalfunctionMar 23, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A LEAK AT THE 15MM CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866367 ↗