SHERIDAN 5-16035Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14026704941169), received between Dec 24, 2025 and Jul 13, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00323, 3003898360-2026-00295 AND 3003898360-2026-00297.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808427 ↗
• MalfunctionJul 13, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00323, 3003898360-2026-00295.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808408 ↗
• MalfunctionJul 13, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00295 AND 3003898360-2026-00297.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808373 ↗
• MalfunctionJul 7, 2026Leak/Splash

  IT WAS REPORTED THAT "THE TUBE PRE-TEST PASSED. THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON A PATIENT. CHANGE TO A NEW TUBE." NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742041 ↗
• MalfunctionMar 4, 2026Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504988 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971988 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT: "ON (B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971813 ↗
• MalfunctionDec 24, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT: "ANAESTHESIOLOGIST COMPLAINED THAT THE MATERIAL OF TUBE WAS TOO SOFT AND COULD NOT HOLD THE STRENGTH. CHANGE TWO 35FR_TUBES & ONE 28FR_TUBE AND COULD NOT BUILD THE AIRWAY. TRIED BLOCKER AND BUILT UP PATIENT AIRWAY." ASSOCIATED COMPLAINTS 3003898360-2025-00935 AND 3003898360-2025-00936.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887291 ↗
• MalfunctionDec 24, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT: "ANAESTHESIOLOGIST COMPLAINED THAT THE MATERIAL OF TUBE WAS TOO SOFT AND COULD NOT HOLD THE STRENGTH. CHANGE TWO 35FR_TUBES & ONE 28FR_TUBE AND COULD NOT BUILD THE AIRWAY. TRIED BLOCKER AND BUILT-UP PATIENT AIRWAY." ASSOCIATED COMPLAINTS 3003898360-2025-00933 AND 3003898360-2025-00936.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887282 ↗