HUDSON RCI IPN044861Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04026704397662), received between Nov 19, 2021 and Jul 7, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K851856); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 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 22410492 ↗
• MalfunctionJul 7, 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 22410276 ↗
• MalfunctionJul 3, 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 22395054 ↗
• 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 22395030 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THE RETURNED PHOTO OF THE DEVICE SHOWS A DEFLATED PILOT BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664734 ↗
• MalfunctionNov 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2024, DURING VENTILATION OF THE RIGHT SINGLE LUNG, IT WAS FOUND TO BE UNVENTILATED, AND AFTER REMOVING THE DOUBLE LUMEN TUBE, IT WAS FOUND THAT THE HEAD END OF THE DOUBLE LUMEN TUBE WAS BENT, AND AFTER RE-MOLDING AND RE-INTUBATION, THE RIGHT HEAD END OF THE DOUBLE LUMEN TUBE WAS STILL BENT, AND THE SINGLE LUNG COULD NOT BE VENTILATED. THE TUBE WAS REPLACED WITH A NORMAL ONE." THE PATIENT DID NOT DESATURATE AND WAS REPORTED AS FINE POST THE PROCEDURE WITH NO HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664428 ↗
• MalfunctionSep 20, 2024Device Damaged Prior to Receipt by User; Contamination /Decontamination Problem; Device Damaged Prior to Receipt by User; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, "ON (B)(6) 2024, DAMAGED TO THE PRODUCT'S OUTER PACKAGING. THIS PRODUCT WAS OPENED FROM THE CARTON AND FOUND THAT THE PAPER-PLASTIC PACKAGING WAS NOT FULLY CLOSED AND THERE WAS A LARGE OPENING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265429 ↗
• MalfunctionOct 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011713 ↗
• MalfunctionNov 19, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "THE DOCTOR FOUND PRODUCT PACKAGE SEALED INCOMPLETELY DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846890 ↗
• MalfunctionNov 19, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "THE DOCTOR FOUND PRODUCT PACKAGE SEALED INCOMPLETELY DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846192 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K851856. One submission often covers many models, so check the product and lot details in each record.

• Z-0703-2020 · Oct 30, 2019 · Terminated
  HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, admini
• Z-2368-2015 · Jun 1, 2015 · Terminated
  HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bro
• Z-0681-05 · Feb 23, 2005 · Terminated
  Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; H
• Z-0680-05 · Feb 23, 2005 · Terminated
  Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc.,