HUDSON RCI IPN044906Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026704398102), received between Apr 9, 2024 and Sep 5, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

• MalfunctionSep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT: "PATIENT INTUBATED X3 WITH "PERFORMED, CUFFED TRACHEAL TUBE, NASAL" ANESTHESIA STATES THAT THE CUFFS WERE CHECKED PRIOR TO INTUBATION. CUFFS DID NOT HOLD AIR AFTER INTUBATION X3. PATIENT WAS THEN INTUBATED ORALLY. NO HARM TO THE PATIENT WAS COMMUNICATED." ASSOCIATED COMPLAINTS 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 AND 3003898360-2024-01070.

  Patient problems: Insufficient Information

  MAUDE report 20143262 ↗
• MalfunctionAug 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "PATIENT INTUBATED X3 WITH "PERFORMED, CUFFED TRACHEAL TUBE, NASAL" ANESTHESIA STATES THAT THE CUFFS WERE CHECKED PRIOR TO INTUBATION. CUFFS DID NOT HOLD AIR AFTER INTUBATION X3. PATIENT WAS THEN INTUBATED ORALLY." ASSOCIATED COMPLAINTS 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 AND 3003898360-2024-01070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105675 ↗
• MalfunctionAug 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "PATIENT INTUBATED X3 WITH "PERFORMED, CUFFED TRACHEAL TUBE, NASAL" ANESTHESIA STATES THAT THE CUFFS WERE CHECKED PRIOR TO INTUBATION. CUFFS DID NOT HOLD AIR AFTER INTUBATION X3. PATIENT WAS THEN INTUBATED ORALLY." ASSOCIATED COMPLAINTS 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 AND 3003898360-2024-01070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105653 ↗
• MalfunctionMay 24, 2024Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES THAT "I HAD AN ISSUE WITH A SHERIDAN BRAND NASAL TUBE REF NUMBER (B)(4), WHERE THERE WAS A HOLE IN THE TUBE AT THE POINT OF CONTACT OF THE PILOT BALLOON TUBING AND THE NTT ITSELF". ADDITIONAL INFORMATION RECEIVED STATES THAT "WE NOTICED AFTER PLACEMENT OF THE NTT WHEN WE ATTEMPTED TO VENTILATE PATIENT. NO PATIENT COMPLICATION, WE WERE ABLE TO HAVE A GOOD ENOUGH SEAL WITH A TEGADERM OVER THE OPENING AND IT WAS A SHORT CASE < 1HR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391141 ↗
• MalfunctionApr 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "WE HAVE RECEIVED COMPLAINTS OF CUFF LEAKS ON THESE TUBES." ADDITIONAL INFORMATION HAS BEEN REQUESTED. ASSOCIATED TO 3003898360-2024-00317.

  Patient problems: Insufficient Information

  MAUDE report 19069287 ↗

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-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-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-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-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-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-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-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-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-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.