HUDSON RCI IPN044728Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04026704396788), received between Mar 9, 2026 and May 12, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 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 25156508 ↗
• MalfunctionMay 12, 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 25156499 ↗
• MalfunctionMay 12, 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 25156488 ↗
• MalfunctionMay 12, 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 25156473 ↗
• MalfunctionMay 12, 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 25156466 ↗
• MalfunctionMay 12, 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 25156410 ↗
• MalfunctionMay 12, 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 25156401 ↗
• MalfunctionMay 12, 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 25156391 ↗
• MalfunctionMay 12, 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 25156265 ↗
• MalfunctionMay 12, 2026Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155946 ↗
• MalfunctionApr 3, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT: "(B)(6) 2026, AFTER INTUBATION, THE PROXIMAL CONNECTOR OF THIS TUBE REPEATEDLY BECAME DISLODGED DURING VENTILATION AND NURSING CARE. DESPITE MULTIPLE ATTEMPTS TO SECURE AND REINFORCE IT, STABLE FIXATION COULD NOT BE ACHIEVED. TO ENSURE AIRWAY SAFETY AND EFFECTIVE VENTILATION FOR THE PATIENT, THE DECISION WAS ULTIMATELY MADE TO REMOVE THIS TUBE AND REPLACE IT WITH A NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773699 ↗
• MalfunctionMar 9, 2026Leak/Splash

  IT WAS REPORTED THAT: "THE CUSTOMER IS REPORTING THE CUFF IS LEAKING (NOT HOLDING AIR)". PRIOR TO USE ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24546441 ↗

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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 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-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-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-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-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-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
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• Z-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• 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
• 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/

…and 12 more.