HUDSON RCI IPN048902Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704616814), received between Sep 9, 2021 and Jun 3, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED THAT IN THE NICU THEY HAD AN EMERGENCY AND PULLED A 2.5 TRACH TUBE (5-10405) AND UPON OPENING THE PACKAGE THEY FOUND A 2.0. THE REPORTED DEFECT WAS DETECTED UPON OPENING THE DEVICE FROM PACKAGING, PRIOR TO USE IN A CLINICAL SETTING. ADDITIONAL INFORMATION REPORTED NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597128 ↗
• MalfunctionDec 3, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED "I HAVE A COMPLAINT REGARDING RECENT CHANGES TO THE MARKINGS ON YOUR 2.5 ENDOTRACHEAL TUBES. THESE CHANGES, WHILE THEY MAY BE GUIDED BY CHANGES TO REGULATIONS, HAVE RESULTED IN INCREASED UNPLANNED EXTUBATIONS". NO SPECIFIC EVENT/PATIENT DETAILS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12924091 ↗
• InjuryOct 18, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "THE CUSTOMER CONTACTED US STATING THAT THEY HAVE ITEM # KC5-10405 ET ON HAND THAT IS DEFECTIVE. THEY STATED THAT THE TUBE WAS PLACED IN THE PATIENT, THE PATIENT STARTED DECOMPENSATING, TRIED TO PASS A SUCTION CATHETER THROUGH, WOULD GET STUCK. EXTUBATED PATIENT AND REINTUBATED WITH NEW TUBE. THEY TOOK THE SUCTION CATHETER TO AN OLD TUBE AND NOTICED INSIDE OF THE TUBE WAS NARROWED, AND THE CATHETER WOULD NOT PASS THROUGH". PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Obstruction/Occlusion

  MAUDE report 12646544 ↗
• InjurySep 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "WE HAD A DEFECTIVE ET TUBE ON ONE OF OUR NICU BABIES. THE ET TUBE NEAR THE STYLET (TIP) HAS AN INTERNAL DEFORMITY AND SUCTION CATHETERS DO NOT PASS THROUGH THE TUBE. WE HAD TO PULL THE TUBE OUT OF THE BABY AND USE ANOTHER TUBE". NO INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Obstruction/Occlusion

  MAUDE report 12448215 ↗
• MalfunctionSep 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "WE HAD A DEFECTIVE ET TUBE ON ONE OF OUR NICU BABIES. THE ET TUBE NEAR THE STYLET (TIP) HAS AN INTERNAL DEFORMITY AND SUCTION CATHETERS DO NOT PASS THROUGH THE TUBE. WE HAD TO PULL THE TUBE OUT OF THE BABY AND USE ANOTHER TUBE". NO INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 12448118 ↗

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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• 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
• 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-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 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.