Shiley 76251Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 40884521157348), received between Dec 30, 2019 and May 27, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE WHEN PLACING THE MOUTH GAG FOR THE SURGERY. THE PLASTIC OF THE TUBE WAS DESCRIBED AS FLIMSIER AND MORE PRONE TO COLLAPSING AT THE TOP OF THE TUBE THAT WAS CONNECTED TO THE GAS MACHINE CIRCUIT NEAR THE TUBE CONNECTOR. THE TUBE WAS REPOSITIONED ON THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089989 ↗
• MalfunctionMay 23, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE, WHEN PLACING THE MOUTH GAG FOR THE SURGERY, THE PLASTIC OF THE TUBE WAS DESCRIBED AS FLIMSIER AND MORE PRONE TO COLLAPSING AT THE TOP OF THE TUBE THAT CONNECTS TO THE GAS MACHINE CIRCUIT NEAR THE TUBE CONNECTOR. THE TUBE WAS REPOSITIONED ON THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078625 ↗
• InjuryMar 11, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF CAME OFF THE TUBE AND WENT INTO PATIENT'S AIRWAY. THE CUFF WAS RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462133 ↗
• MalfunctionDec 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, UPON OPENING THE PRODUCT PACKAGE, THE CUFF WAS DAMAGED AND COULD NOT BE USED. THERE WAS A RIP FROM THE HOLE IN THE SIDE TO THE END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9530131 ↗