HUDSON RCI IPN046759Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04026704588787), received between Apr 13, 2021 and Mar 30, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT: "PT WAS INTUBATED WITH 7.5 ETT, HOLE PRESENT IN THE BALLOON (UNABLE TO KEEP INFLATED S/P INTUBATION). TUBE IMMEDIATELY REMOVED AND REPLACED WITH NEW ETT. NO HARM TO PT. UNABLE TO SEE LEAK IN BALLOON UNTIL BALLOON FILLED WITH SALINE AND LEAK WAS VIZUALIZED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727893 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT: "SIZE 7.5 SHERIDAN ET TUBES NOT HOLDING AIR AND REQUIRING UP TO 40-60 CMH20 TO SEAL AND STILL HEARING GURGLING IN PATIENTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452424 ↗
• InjuryMar 4, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "ETT REPEATEDLY POPPED OFF AT THE HUB RESULTING IN AN ETT EXCHANGE. PATIENT WAS ON A PEEP OF 14 FOR LUNG RECRUITMENT. WITH DISCONNECTIONS, PT WOULD DESAT AND TAKE TIME TO RECOVER FROM EACH EVENT." PATIENT WAS REPORTED AS FINE POST THE INCIDENT WITH NO REPORTED HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 3003898360-2025-00193.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21512617 ↗
• InjuryMar 4, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT: "ETT REPEATEDLY POPPED OFF AT THE HUB RESULTING IN AN ETT EXCHANGE. PATIENT WAS ON A PEEP OF 14 FOR LUNG RECRUITMENT. WITH DISCONNECTIONS, PT WOULD DESAT AND TAKE TIME TO RECOVER FROM EACH EVENT." PATIENT WAS REPORTED AS FINE POST THE INCIDENT WITH NO REPORTED HARM OR CONSEQUENCE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21512590 ↗
• MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "ETT , LEAK DETECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298877 ↗
• MalfunctionMar 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: 7.5 ETT, BALLOON INFLATES BUT DOES NOT RETAIN AIR. NO HARM TO PATIENT, SECOND ETT WAS IMMEDIATELY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967280 ↗
• MalfunctionJul 20, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT IMMEDIATELY FOLLOWING INTUBATION, "A TOTAL CUFF FAILURE" WAS NOTED. NO PATIENT HARM OR INJURY. PER THE CUSTOMER, OTHER DETAILS OF THE EVENT AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360782 ↗
• MalfunctionApr 5, 2023Gas/Air Leak; Gas/Air Leak

  IT IS REPORTED THAT "BALLOON DOES NOT HOLD AIR". AT THE TIME OF THIS REPORT IT IS UNKNOWN IF THIS DEFECT OCCURRED WHILE IN USE ON A PATIENT, HOWEVER, ADDITIONAL CLARIFYING QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16685831 ↗
• MalfunctionApr 5, 2023Gas/Air Leak; Gas/Air Leak

  IT IS REPORTED THAT "BALLOON DOES NOT HOLD AIR". AT THE TIME OF THIS REPORT IT IS UNKNOWN IF THIS DEFECT OCCURRED WHILE IN USE ON A PATIENT, HOWEVER, ADDITIONAL CLARIFYING QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16685821 ↗
• MalfunctionApr 5, 2023Gas/Air Leak; Gas/Air Leak

  IT IS REPORTED THAT "BALLOON DOES NOT HOLD AIR". AT THE TIME OF THIS REPORT IT IS UNKNOWN IF THIS DEFECT OCCURRED WHILE IN USE ON A PATIENT, HOWEVER, ADDITIONAL CLARIFYING QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685773 ↗
• MalfunctionApr 5, 2023Gas/Air Leak; Gas/Air Leak

  IT IS REPORTED THAT "BALLOON DOES NOT HOLD AIR". AT THE TIME OF THIS REPORT IT IS UNKNOWN IF THIS DEFECT OCCURRED WHILE IN USE ON A PATIENT, HOWEVER, ADDITIONAL CLARIFYING QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685744 ↗
• MalfunctionApr 5, 2023Leak/Splash; Leak/Splash

  IT IS REPORTED THAT BALLOON DOES NOT HOLD AIR. AT THE TIME OF THIS REPORT IT IS UNKNOWN IF THIS DEFECT OCCURRED WHILE IN USE ON A PATIENT, HOWEVER, ADDITIONAL CLARIFYING QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16685667 ↗
• MalfunctionApr 22, 2022Inflation Problem; Inflation Problem

  COMPLAINT FROM MAUDE DATABASE: IT WAS REPORTED "PATIENT WAS INTUBATED WITH THE ET TUBE, BUT AS THE TUBE BALLOON WAS BEING INFLATED, IT DID NOT GIVE THE PROPER SEAL NEEDED TO HELP THE PATIENT. EXTUBATION WAS NEEDED TO BE DONE, AND PATIENT WAS RE-INTUBATED". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14190252 ↗
• MalfunctionMar 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED "CUFF WOULD NOT STAY INFLATED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13841494 ↗
• MalfunctionApr 14, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "CRNA LEAD (KARI COLE CRNA) REPORTED 5 OF THE 7.5 ETT'S EXPERIENCING LEAKING CUFFS WHEN TESTING THEM PRIOR TO INSERTION INTO A PATIENT". NO PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BEFORE USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667790 ↗
• MalfunctionApr 14, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "CRNA LEAD ((B)(6) CRNA) REPORTED 5 OF THE 7.5 ETT'S EXPERIENCING LEAKING CUFFS WHEN TESTING THEM PRIOR TO INSERTION INTO A PATIENT". NO PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BEFORE USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667765 ↗
• MalfunctionApr 14, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "CRNA LEAD ((B)(6) CRNA) REPORTED 5 OF THE 7.5 ETT'S EXPERIENCING LEAKING CUFFS WHEN TESTING THEM PRIOR TO INSERTION INTO A PATIENT". NO PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BEFORE USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667748 ↗
• MalfunctionApr 14, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "CRNA LEAD ((B)(6) CRNA) REPORTED 5 OF THE 7.5 ETT'S EXPERIENCING LEAKING CUFFS WHEN TESTING THEM PRIOR TO INSERTION INTO A PATIENT". NO PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BEFORE USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667713 ↗
• MalfunctionApr 13, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "CRNA LEAD (KARI COLE CRNA) REPORTED 5 OF THE 7.5 ETT'S EXPERIENCING LEAKING CUFFS WHEN TESTING THEM PRIOR TO INSERTION INTO A PATIENT". NO PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BEFORE USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661390 ↗

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-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-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-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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1762-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-222
• 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-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-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.