Shiley 76265Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 40884521157386), received between Nov 6, 2020 and May 19, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Disconnection” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046373 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046352 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046347 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046242 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046195 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046183 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046161 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046141 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045977 ↗
• MalfunctionMay 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTORS OF THESE TEN ENDOTRACHEAL TUBES KEPT DISCONNECTING FROM THE ANESTHESIA TUBES DURING ANESTHETIC PROCEDURES. THIS ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045967 ↗
• MalfunctionDec 29, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, WHEN THEY OPENED THE PACKAGE, THE CONNECTOR WAS NOT IN THE END OF THE TUBE BUT WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11092192 ↗
• MalfunctionDec 28, 2020Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHILE PREPARING FOR INTUBATION, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077920 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077840 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, WHILE PREPARING FOR INTUBATION, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077654 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, WHILE PREPARING FOR INTUBATION, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11075103 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, WHILE PREPARING FOR INTUBATION, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11075077 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, PRIOR TO USE ON PATIENT, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11075046 ↗
• MalfunctionNov 12, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF CONNECTOR WAS FALLING OFF AND WOULD NOT HOLD ITS CONNECTION ON THE TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: No Information

  MAUDE report 10829259 ↗
• MalfunctionNov 10, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CONNECTOR ON THE DEVICE'S CUFF WAS FALLING OFF AND IT WOULD NOT HOLD ITS CONNECTION ON THE 6.5. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10815633 ↗
• MalfunctionNov 6, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF CONNECTOR WAS FALLING OFF AND WOULD NOT HOLD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802741 ↗