HUDSON RCI IPN044731Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04026704396818), received between Jan 16, 2024 and Aug 27, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50477647 ↗
• MalfunctionJul 31, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101963 ↗
• MalfunctionJul 9, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGE TO A NEW TUBE." NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769479 ↗
• MalfunctionJul 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT "ETT CUFF WOULD NOT HOLD PRESSURE AFTER PLACEMENT. SOMETIMES THE LEAK WAS OBVIOUS (CUFF DEFLATED QUICKLY), WHILE OTHER TIMES IT WAS A SLOW LEAK OVER TIME. IN ALL OF THESE CASES, THE PATIENT ULTIMATELY REQUIRED AN ETT EXCHANGE. THE CUFFS ARE ROUTINELY TESTED BEFORE INTUBATION AND APPEAR TO BE FUNCTIONING PROPERLY AT THE TIME OF PLACEMENT, BUT IT'S DIFFICULT TO IDENTIFY A SLOW LEAK IN THE MOMENTS PRIOR TO INTUBATION. OVER THE PAST 9 MONTHS, THERE HAVE BEEN 6 INCIDENTS WHERE A TUBE HAD A SLOW LEAK WHILE IN THE PATIENT. IN ONE INCIDENT, THE TUBE COMPLETELY BURST AND FAILED. THERE WAS PATIENT INVOLVEMENT AND NO HARM." TWO ISSUES REPORTED (CUFF LEAK AND BURST). ASSOCIATED MDRS: 3003898360-2026-00290. ADDITIONAL INFORMATION RECEIVED ON JUNE 16, 2026, INDICATED THAT THERE WERE NO REPORTS OF PATIENT HARM OR ADVERSE HEALTH CONSEQUENCES. HOWEVER, PATIENTS REQUIRED REINTUBATION IN THE REPORTED EVENTS. NO INFORMATION IS AVAILABLE REGARDING THE INDIVIDUAL PATIENTS' CURRENT CONDITION. THE TIME THE TUBES REMAINED IN PLACE BEFORE THE ISSUE WAS DETECTED VARIED FROM MINUTES TO HOURS. SOME PATIENTS EXPERIENCED DESATURATION, WITH VARYING DEGREES OF SEVERITY. THE DEVICES WERE TESTED

  Patient problems: Low Oxygen Saturation

  MAUDE report 25727770 ↗
• MalfunctionMay 25, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. THE TUBE WAS REPLACED." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273323 ↗
• MalfunctionMay 25, 2026Decoupling

  IT WAS REPORTED THAT "CUSTOMER STATES THE ETT HAD ISSUES WITH THE PLASTIC CONNECTOR DISCONNECTING FROM CIRCUIT 5 MINUTES AFTER INTUBATION. THE RESPIRATORY THERAPIST USED ANOTHER CONNECTOR. THERAPY WAS NOT DELAYED, AND THE PATIENT IS FINE AND DID NOT DESATURATE." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE RESPIRATORY THERAPIST USED ANOTHER CONNECTOR FROM A DIFFERENT ETT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272644 ↗
• MalfunctionMay 21, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245429 ↗
• MalfunctionMay 7, 2026Product Quality Problem

  IT WAS REPORTED THAT "STAFF HAS REPORTED THAT THE BALLOONS HAVE FAILED AFTER INTUBATION, REQUIRING RE-INTUBATION WITH NEW ET TUBES. IN ONE CASE, THIS OCCURRED TWICE WITH THE SAME PATIENT, AND IN ANOTHER CASE, IT OCCURRED ONCE." ADDITIONAL INFORMATION RECEIVED ON APRIL 14, 2026, INDICATED THAT "TWO ET TUBES WERE INVOLVED, AND A TOTAL OF TWO PATIENTS WERE INVOLVED. THE DEFECT WAS NOTICED IMMEDIATELY AFTER INTUBATION. NO HARM TO THE PATIENT, BUT MEDICAL INTERVENTION WAS REQUIRED; A BOUGIE WAS USED TO RE-INTUBATE. THE CURRENT CONDITION OF THE PATIENTS IS STABLE. DEVICES WERE PRE-TESTED PER THE IFU." ASSOCIATED MDRS: 3003898360-2026-00218.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119544 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "31 MARCH 2026, DURING USE, THE TUBE BODY AND TUBE CONNECTOR DETACHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966073 ↗
• MalfunctionApr 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT: "(B)(6) 2026, THE CONNECTION BETWEEN THE TRACHEAL TUBE AND THE CIRCUIT IS PRONE TO DETACHMENT. THERE WAS NO REPORTED PATIENT HARM, NO DESATURATION. THE DEVICE WAS REPLACED TO RESOLVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924749 ↗
• MalfunctionApr 20, 2026Leak/Splash

  IT WAS REPORTED THAT: "ON (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 24924126 ↗
• MalfunctionApr 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838592 ↗
• MalfunctionFeb 26, 2026Gas/Air Leak

  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 24454168 ↗
• MalfunctionFeb 17, 2026Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363000 ↗
• MalfunctionFeb 9, 2026Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE. THERE WAS NO HARM OR HEALTH CONSEQUENCE FOR THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291184 ↗
• MalfunctionFeb 4, 2026Migration or Expulsion of Device; Gas/Air Leak

  IT WAS REPORTED THAT: "ON (B)(6) 2025, THE TRACHEAL TUBE ACCIDENTALLY DISLODGED DURING USE, AND THE CUFF WAS FOUND TO BE LEAKING. IT WAS IMMEDIATELY DISCONTINUED AND REPLACED. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257365 ↗
• MalfunctionJan 26, 2026Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176132 ↗
• MalfunctionDec 26, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF DIDN'T INFLATE DURING THE TEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896860 ↗
• MalfunctionDec 22, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE PILOT BALLOON DIDN'T INFLATE DURING THE TEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866067 ↗
• MalfunctionDec 4, 2025Gas/Air Leak; Gas/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 23713616 ↗
• InjuryOct 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "ON SEPTEMBER 19TH, THE PATIENT UNDERWENT A NASAL TRACHEAL INTUBATION. ON SEPTEMBER 20TH, IT WAS DISCOVERED THAT THE TRACHEAL TUBE WAS LEAKING AIR. IMMEDIATELY, THE SAME BATCH NUMBER OF TRACHEAL TUBE WAS REPLACED. HOWEVER, THE AIRBAG COULD NOT BE INFLATED. THE PATIENT'S BLOOD OXYGEN LEVEL WAS LOW AND THEY WERE EXPERIENCING SHORTNESS OF BREATH. AFTER REPLACING WITH A SUBGLOTTIC TRACHEAL TUBE, THERE WAS NO LEAKAGE ANYMORE. THE PATIENT NO LONGER HAD SHORTNESS OF BREATH AND THEIR BLOOD OXYGEN LEVEL RETURNED TO NORMAL." ASSOCIATED COMPLAINT 3003898360-2025-00780.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23377335 ↗
• InjuryOct 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "THE CUFF DEFLATED ON US DURING THE SURGERY. CUSTOMER REPLACED THE ETT TUBE. THE PATIENT DESATURATED TO 88% FROM THE CUFF DEFLATION. THE EVENT OCCURRED 20 MINUTES INTO THE PROCEDURE. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE AND WAS DISCHARGED TO HOME AFTER THE PROCEDURE."

  Patient problems: Low Oxygen Saturation

  MAUDE report 23365772 ↗
• MalfunctionOct 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6), THE PATIENT UNDERWENT A NASAL TRACHEAL INTUBATION. ON (B)(6), IT WAS DISCOVERED THAT THE TRACHEAL TUBE WAS LEAKING AIR. IMMEDIATELY, THE SAME BATCH NUMBER OF TRACHEAL TUBE WAS REPLACED. HOWEVER, THE AIRBAG COULD NOT BE INFLATED. THE PATIENT'S BLOOD OXYGEN LEVEL WAS LOW AND THEY WERE EXPERIENCING SHORTNESS OF BREATH. AFTER REPLACING WITH A SUBGLOTTIC TRACHEAL TUBE, THERE WAS NO LEAKAGE ANYMORE. THE PATIENT NO LONGER HAD SHORTNESS OF BREATH AND THEIR BLOOD OXYGEN LEVEL RETURNED TO NORMAL." ASSOCIATED COMPLAINT 3003898360-2025-00779 AND 3003898360-2025-00780.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365432 ↗
• MalfunctionSep 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "A PATIENT IN THE INTENSIVE CARE UNIT (ICU) UNDERWENT ORAL TRACHEAL INTUBATION AND WAS CONNECTED TO A VENTILATOR AT 09:54 ON (B)(6) 2025, AS PER THE DOCTOR'S ORDERS. AT 19:00 ON (B)(6), THE NURSE NOTICED THAT THE CUFF PRESSURE OF THE TRACHEAL TUBE WAS TOO LOW AND THERE WAS AN ABNORMAL SOUND. AFTER RE-INFLATING IT, THE CUFF PRESSURE STILL COULD NOT BE MAINTAINED AT A NORMAL LEVEL. THE DOCTOR WAS IMMEDIATELY ASSISTED IN REPLACING THE TRACHEAL TUBE. AFTER THE REPLACEMENT, THE PATIENT'S VITAL SIGNS WERE STABLE, AND THE CUFF PRESSURE WAS 27 CMH2O."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013887 ↗
• MalfunctionJul 8, 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 22434134 ↗

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-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-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-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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• 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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• 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-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• 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-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-1764-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0

…and 12 more.