HUDSON RCI IPN044855Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04026704397600), received between Nov 28, 2022 and Aug 13, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 reports).

2 other recalls cover devices cleared under the same FDA submission (K961977); 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT: "THE PATIENT UNDERWENT A LUNG LESION RESECTION SURGERY IN THE OPERATING ROOM OF OUR HOSPITAL ON (B)(6) 2025. DURING THE OPERATION, LUNG ISOLATION WAS REQUIRED. THE ANESTHESIOLOGIST USED A DISPOSABLE STERILE BRONCHIAL TUBE FOR BRONCHIAL INTUBATION. AFTER FOLLOWING THE NORMAL OPERATION PROCEDURE, THE DISPOSABLE STERILE BRONCHIAL TUBE COULD NOT BE ADJUSTED WITHIN THE TRACHEA, RESULTING IN POOR ALIGNMENT OF THE BRONCHIAL TUBE AND THE PULMONARY BRONCHUS, AND THUS MAKING IT IMPOSSIBLE TO PERFORM LUNG ISOLATION VENTILATION. WHEN INSERTED INTO THE GLOTTIS, IT HAS DIFFICULTY ROTATING. THE ANESTHESIOLOGIST THEN REMOVED THE DISPOSABLE STERILE BRONCHIAL TUBE AND REPLACED IT WITH A DISPOSABLE DOUBLE-LUMEN BRONCHIAL TUBE FOR RE-INTUBATION. THE LUNG ISOLATION VENTILATION WAS SUCCESSFULLY CARRIED OUT, AND THE SUBSEQUENT SURGERY PROCEEDED NORMALLY. THE SECOND INTUBATION CAUSED PAIN TO THE PATIENT AND INCREASED RISKS. THE DOCTOR REPORTED THAT THE TEXTURE OF THIS BATCH OF TUBES WAS TOO SOFT AND UNABLE TO SUPPORT, MAKING IT DIFFICULT TO MOVE DURING ADJUSTMENT. THERE WAS NO OTHER REPORTED PATIENT HARM."

  Patient problems: Pain

  MAUDE report 22794210 ↗
• MalfunctionJul 28, 2025Crack; Leak/Splash; Crack; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629603 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE TRACHEAL CUFF WAS FOUND OUT THAT IT COULD NOT BE INFLATED DURING THE TEST.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629085 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

  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 22410523 ↗
• MalfunctionJul 3, 2025Leak/Splash; Leak/Splash

  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 22394693 ↗
• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(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 22156949 ↗
• MalfunctionMay 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "DURING THE SURGERY, AIR LEAKING OCCURRED CONTINUOUSLY SO THAT THE SURGERY COULD NOT BE OPERATED SMOOTHLY."

  Patient problems: Insufficient Information

  MAUDE report 22000582 ↗
• InjuryApr 29, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT: "AFTER INTUBATION, NURSE FOUND PLASTIC SCRAPS INSIDE OF TUBE WHEN SHE WAS TRYING TO EXTRACT SPUTUM. THE PATIENT'S SATURATIONS REMAINED 92~93% DUE TO SURGERY REQUIREMENT. THERE WAS NO REPORTED PATIENT HARM FROM THE INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926789 ↗
• MalfunctionApr 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE, NO HARM TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917855 ↗
• MalfunctionApr 18, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863467 ↗
• MalfunctionApr 18, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863455 ↗
• MalfunctionApr 8, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT: "4 MARCH 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. THE DOCTOR FOUND THE HOLE ON THE BALLOON. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21798978 ↗
• MalfunctionApr 3, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760089 ↗
• MalfunctionApr 3, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760020 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392608 ↗
• MalfunctionNov 29, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809004 ↗
• MalfunctionNov 29, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808950 ↗
• MalfunctionNov 29, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808941 ↗
• MalfunctionNov 19, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: " ON (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 20722154 ↗
• MalfunctionOct 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. IT WAS CHANGED FOR A NEW ONE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE POST THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566936 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6) 2024, THE DOCTOR UNPACKED THE PACKAGE BEFORE SURGERY AND FOUND THAT THE AIRBAG WAS LEAKING. THE ISSUE WAS IDENTIFIED PRIOR TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394792 ↗
• MalfunctionSep 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT"13 AUG 2024, THE NURSE OPENED THE PACKAGING AND FOUND THE BLUE AIRBAG RUPTURED." THE ISSUE WAS IDENTIFIED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145072 ↗
• MalfunctionAug 13, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19970273 ↗
• MalfunctionJul 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19863059 ↗
• MalfunctionMay 9, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: "THE CUFF WOULD NOT INFLATE". THE ISSUE WAS IDENTIFIED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961977. One submission often covers many models, so check the product and lot details in each record.

• Z-2367-2015 · Jun 1, 2015 · Terminated
  HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bron
• Z-0125-2007 · Sep 27, 2006 · Terminated
  Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bro