HUDSON RCI IPN044730Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04026704396801), received between Aug 22, 2023 and May 14, 2026 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

27 other recalls cover devices cleared under the same FDA submission (K822082); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT "THE RT'S NOTICED THE DEPTH MARKINGS ARE UP TO 0.5CM OFF MEASUREMENT." ADDITIONAL INFORMATION RECEIVED ON APRIL 20, 2026, INDICATED THAT "NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178524 ↗
• MalfunctionSep 5, 2025Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT: "WHEN INSTALLING A SHERIDAN TUBE IN THE OR AND THE PATIENT GETS TRANSFERRED IN THE ICU, THEY HAVE ISSUES WITH THE CUFF DEFLATING AND THERE IS A LEAK."

  Patient problems: Insufficient Information

  MAUDE report 22975557 ↗
• MalfunctionSep 5, 2025Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT: "WHEN INSTALLING A SHERIDAN TUBE IN THE OR AND THE PATIENT GETS TRANSFERRED IN THE ICU, THEY HAVE ISSUES WITH THE CUFF DEFLATING AND THERE IS A LEAK.".

  Patient problems: Insufficient Information

  MAUDE report 22975499 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT"(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE THE SECOND TUBE, HE DOCTOR FOUND CUFF LEAKAGE AGAIN. CHANGE THE THIRD TUBE. NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. BOTH THE FIRST ETT AND THE SECOND ETT WERE PRE-TESTED BEFORE THE OPERATION, BUT THE INFLATION OPERATION OF THE BALLOON AFTER PLACEMENT INTO THE PATIENT REVEALED THAT IT COULD NOT BE INFLATED, AND RE- CATHETERIZATION WAS PERFORMED. NO VISIBLE DAMAGE (I.E., TORN, HOLE, ETC)" ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870604 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE THE SECOND TUBE, HE DOCTOR FOUND CUFF LEAKAGE AGAIN. CHANGE THE THIRD TUBE. NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. BOTH THE FIRST ETT AND THE SECOND ETT WERE PRE-TESTED BEFORE THE OPERATION, BUT THE INFLATION OPERATION OF THE BALLOON AFTER PLACEMENT INTO THE PATIENT REVEALED THAT IT COULD NOT BE INFLATED, AND RE- CATHETERIZATION WAS PERFORMED. NO ANY VISIBLE DAMAGE (I.E., TORN, HOLE, ETC)" ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870591 ↗
• MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, WHEN TUBE WAS INSERTED, THERE WAS A QUALITY PROBLEM WITH THE SUCTION BALLOON. AFTER THE GAS WAS INJECTED, THE BALLOON WAS FILLED BUT THEN THE BALLOON COLLAPSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141769 ↗
• MalfunctionMay 19, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042171 ↗
• MalfunctionJan 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "ON (B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE DURING ORAL IMPLANTATION. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158423 ↗
• MalfunctionJan 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT" ON (B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE DURING ORAL IMPLANTATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158246 ↗
• InjurySep 17, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "OVER THE LAST WEEK, I HAVE HAD THREE COMPLAINTS REGARDING ENDOTRACHEAL TUBES. THE ISSUE IS THAT THE PILOT BALLOON AND CUFF BOTH INFLATE WELL WHILE TESTING BEFORE INTUBATION. ONCE INTUBATED THE PILOT BALLOON DEFLATES, CAUSING NEGATIVE PRESSURE. THE PATIENT'S OXYGEN SATURATION DROPPED CAUSING THE PHYSICIAN TO EXTUBATE AND REINTUBATE WITH A NEW ET TUBE. THE THERAPIST STATED THE PILOT BALLOON LOSES AIR AND CREATES A NEGATIVE PRESSURE DEFLATING THE CUFF. THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT." ASSOCIATED COMPLAINTS 3003898360-2024-01127, 3003898360-2024-01126 AND 3003898360-2024-01215.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20234692 ↗
• InjurySep 10, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "OVER THE LAST WEEK, I HAVE HAD THREE COMPLAINTS REGARDING ENDOTRACHEAL TUBES. IT WAS THE ON THE TWO FOLLOWING PRODUCTS. THE ISSUE IS THAT THE PILOT BALLOON AND CUFF BOTH INFLATE WELL WHILE TESTING BEFORE INTUBATION. ONCE INTUBATED THE PILOT BALLOON DEFLATES, CAUSING NEGATIVE PRESSURE. THE PATIENT'S OXYGEN SATURATION DROPPED CAUSING THE PHYSICIAN TO EXTUBATE AND REINTUBATE WITH A NEW ET TUBE. THE THERAPIST STATED THE PILOT BALLOON LOSES AIR AND CREATES A NEGATIVE PRESSURE DEFLATING THE CUFF. THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT." ASSOCIATED COMPLAINTS 3003898360-2024-01127 AND 3003898360-2024-01126.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20178860 ↗
• MalfunctionSep 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THERE WAS NO PATIENT INVOLVEMENET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140157 ↗
• MalfunctionJun 13, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED "THE INFLATION CUFF ON TWO TUBES WERE NOT PROPERLY GLUES TO THE TUBE, AFFECTING ITS PERFORMANCE." THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "HEALTHY". ASSOCIATED MDR NUMBER: 3003898360-2024-00679.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532624 ↗
• MalfunctionMay 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND THE CUFF TO BE LEAKING WHEN USING ON THE PATIENT." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEYW ERE REPORTED AS FINE WITH NO DESATURATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297719 ↗
• MalfunctionMay 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." ADDITIONAL INFORMATION REPORTED THIS EVENT OCCURED DURING USE. THE USER CHANGED TO ANOTHER TUBE AND THE PATIENT WAS REINTUBATED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296684 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." ADDITIONAL INFORMATION REPORTED THIS EVENT OCCURED DURING USE. THE USER CHANGED TO ANOTHER TUBE AND THE PATIENT WAS REINTUBATED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282131 ↗
• MalfunctionMay 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "WE HAVE BEEN EXPERIENCING ISSUES WITH THE CUFFS ON OUR ENDOTRACHEAL TUBES. I HAVE TESTED ONE IN MY OFFICE AND IT IS LEAKING AIR/PRESSURE." THIS WAS FOUND PRIOR TO USE. THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249045 ↗
• MalfunctionApr 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "WE HAVE BEEN EXPERIENCING ISSUES WITH THE CUFFS ON OUR ENDOTRACHEAL TUBES THROUGHOUT THE HOSPITAL. I HAVE TESTED ONE IN MY OFFICE AND IT IS LEAKING AIR/PRESSURE." THIS WAS FOUND PRIOR TO USE THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165769 ↗
• MalfunctionMar 25, 2024Gas/Air Leak; Gas/Air Leak

  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 18967235 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE PRIOR TO USE ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597217 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K822082. One submission often covers many models, so check the product and lot details in each record.

• Z-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• Z-2316-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm,
• Z-2314-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009,
• Z-2313-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0
• Z-2311-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
• Z-2315-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g)
• Z-2312-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10
• Z-2318-2019 · Jul 30, 2019 · Terminated
  Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
• Z-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1766-2019 · May 24, 2019 · Terminated
  Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-
• Z-1760-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm,
• Z-1763-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/
• Z-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• Z-1761-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-2

…and 12 more.