HUDSON RCI IPN044860Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04026704397655), received between Apr 8, 2024 and Jun 6, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K851856); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

  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 22156992 ↗
• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22156747 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND BLUE BALLOON CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663582 ↗
• MalfunctionOct 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND WHITE BALLOON CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558986 ↗
• MalfunctionOct 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND TWO BLUE BALLOON CUFFS WERE LEAKING WHEN DOING TESTING BEFORE USE ON PATIENT. DEVICE WAS CHANGED FOR A NEW ONE." ASSOCIATED COMPLAINTS 3003898360-2024-01374.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558762 ↗
• MalfunctionOct 29, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND TWO BLUE BALLOON CUFFS WERE LEAKING WHEN DOING TESTING BEFORE USE ON PATIENT. DEVICE WAS CHANGED FOR A NEW ONE." ASSOCIATED COMPLAINTS 3003898360-2024-01375.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558492 ↗
• MalfunctionApr 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." NO PATIENT INVOLVEMENT. THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059392 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K851856. One submission often covers many models, so check the product and lot details in each record.

• Z-0703-2020 · Oct 30, 2019 · Terminated
  HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, admini
• Z-2368-2015 · Jun 1, 2015 · Terminated
  HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bro
• Z-0681-05 · Feb 23, 2005 · Terminated
  Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; H
• Z-0680-05 · Feb 23, 2005 · Terminated
  Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc.,