HUDSON RCI IPN048873Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 14026704616524), received between Feb 8, 2021 and Apr 12, 2023 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (16 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED ISSUE: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726442 ↗
• MalfunctionApr 3, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: THE DOCTOR FOUND CUFF LEAKAGE BEFORE USING THE DEVICE ON A PATIENT. THIS OCCURRED IN A CLINICAL SETTING. THE DEVICE WAS REPLACED WITH A NEW ONE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16666389 ↗
• MalfunctionMar 27, 2023Break; Break

  REPORTED ISSUE: THE CUFF WOULD NOT INFLATE. THE CUSTOMER WAS UNABLE TO ANSWER MULTIPLE INQUIRIES REGARDING IF THE EVENT HAPPENED WHILE IN USE ON A PATIENT, HOW LONG THE DEVICE WAS IN USE, IF MEDICAL INTERVENTION WAS REQUIRED, IF REINTUBATION WAS REQUIRED, IF DESATURATION OCCURRED, AND THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16622558 ↗
• MalfunctionMar 15, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: THE DOCTOR FOUND THE CUFF LEAKAGE WHEN USING IT ON A PATIENT. A NEW TUBE WAS USED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550897 ↗
• MalfunctionFeb 14, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED EVENT: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. IT WAS CHANGED TO A NEW ONE. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374255 ↗
• MalfunctionFeb 14, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED EVENT: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. IT WAS CHANGED TO A NEW ONE. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374200 ↗
• MalfunctionFeb 14, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED EVENT: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. IT WAS CHANGED TO A NEW ONE. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374038 ↗
• MalfunctionFeb 14, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED EVENT: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. IT WAS CHANGED TO A NEW ONE. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373922 ↗
• MalfunctionJan 9, 2023Deflation Problem; Deflation Problem

  REPORTED ISSUE: THE ED PHYSICIAN INTUBATED A PATIENT AND HAD DIFFICULTY WITH THE TUBE. RESPIRATORY CHECKED THE BALLOON PRIOR TO INTUBATION AND IT INFLATED PROPERLY. AFTER INTRODUCING THE TUBE, IT WOULD NOT HOLD AIR. THIS HAPPENED ON 2 DIFFERENT ET TUBES, 3RD HELD AIR. THE TUBE IS A 7.5MM HUDSON RCI TUBE, LOT 73D220280 WITH A 04/10/2027 EXPIRATION. THIS SAME SITUATION HAPPENED WITH TWO OTHER 8.0 TUBE ET TUBES. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16125076 ↗
• MalfunctionJan 9, 2023Deflation Problem; Deflation Problem

  REPORTED ISSUE: THE ED PHYSICIAN INTUBATED A PATIENT AND HAD DIFFICULTY WITH THE TUBE. RESPIRATORY CHECKED THE BALLOON PRIOR TO INTUBATION AND IT INFLATED PROPERLY. AFTER INTRODUCING THE TUBE, IT WOULD NOT HOLD AIR. THIS HAPPENED ON 2 DIFFERENT ET TUBES, 3RD HELD AIR. THE TUBE IS A 7.5MM HUDSON RCI TUBE, LOT 73D220280 WITH A 04/10/2027 EXPIRATION. THIS SAME SITUATION HAPPENED WITH TWO OTHER 8.0 TUBE ET TUBES. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16123796 ↗
• MalfunctionDec 22, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE CUFF CANNOT DEFLATE WHEN USING IT ON A PATIENT. A NEW ONE WAS USED AND THERE WAS NO DESATURATION OR OTHER PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038044 ↗
• MalfunctionNov 17, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. IT WAS CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814583 ↗
• MalfunctionNov 2, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED ON (B)(6)2022 THAT THE DOCTOR FOUND THE CUFF LEAKING WHILE USING IT ON A PATIENT. THE DEVICE WAS CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. THE CURRENT PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717632 ↗
• MalfunctionOct 13, 2022Material Rupture; Material Rupture

  THE REPORTED COMPLAINT STATES THAT: "THE DOCTOR FOUND CUFF RUPTURED WHEN USING ON PATIENT. THEN CHANGED TO A NEW ONE. NO IMPACT TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596335 ↗
• MalfunctionOct 7, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CUFF RUPTURED WHEN USING ON PATIENT. THEN CHANGED TO A NEW ONE. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563146 ↗
• MalfunctionMar 17, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT AND CHANGED NEW ONE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794678 ↗
• MalfunctionMar 17, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT AND CHANGED NEW ONE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794624 ↗
• MalfunctionDec 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080397 ↗
• MalfunctionDec 17, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE CUFF IS LEAKING. THE CUFF'S WALLS STICK TOGETHER AFTER INTUBATION". UNKNOWN WHEN ISSUE WAS FIRST IDENTIFIED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. ATTEMPTS TO CUSTOMER FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 13026239 ↗
• MalfunctionSep 14, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF DID NOT INFLATE DURING A LEAK TEST BEFORE USE ON A PATIENT. THEREFORE, A NEW UNIT WAS OPENED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470621 ↗
• MalfunctionAug 26, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "ON (B)(6) 2021, THE ANAESTHESISTS OBSERVED THAT THE CUFF OF THE ET TUBE DEFLATES. IT IS IMPOSSIBLE TO MAINTAIN A CONSTANT VOLUME AND WHEN CHECKING WITH THE MANOMETER IT SHOWED A DECREASE IN PRESSURE. CLINICAL CONSEQUENCES: THE ET TUBE WAS REPLACED WITHOUT ANY CONSEQUENCES FOR THE PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12373209 ↗
• MalfunctionMar 22, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE IN THE CLINICAL SETTING BEFORE USING ON PATIENT, NO IMPACT ON THE OPERATION". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11545960 ↗
• MalfunctionMar 22, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE IN THE CLINICAL SETTING BEFORE USING ON PATIENT, NO IMPACT ON THE OPERATION". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11545949 ↗
• MalfunctionFeb 11, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "A DISPOSABLE TRACHEAL TUBE WAS USED FOR THE TREATMENT OF THE PATIENT. DURING THE USE, IT WAS FOUND THAT THE BALLOON WAS LEAKING. THEN REPLACED NEW ONE WHICH HAS NO EFFECT ON THE PATIENT". NO PATIENT HARM OR INJURY REPORTED. NO DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11316209 ↗
• MalfunctionFeb 8, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "DOCTOR FOUND THE CUFF LEAKAGE DURING FUNCTION TEST PRIOR TO THE PATIENT". DEVICE REPLACED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298235 ↗

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-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-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-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-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-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-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-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-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-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-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

…and 12 more.