HUDSON RCI IPN046756Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04026704588756), received between Aug 1, 2023 and Sep 2, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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.

• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22932092 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931785 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931750 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "7.5 ET TUBE FAILED TO HOLD AIR. DURING USE ON PATIENT. NO FURTHER INFORMATION AVAILABLE."

  Patient problems: Insufficient Information

  MAUDE report 22931745 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931726 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931725 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931721 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931712 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22931711 ↗
• MalfunctionAug 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "7.5 ET TUBE FAILED TO HOLD AIR". NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22885143 ↗
• MalfunctionMay 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: CUFFS WERE LOSING AIR. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS: 3003898360-20 24-00417 AND 3003898360-2024-00418 .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227925 ↗
• MalfunctionMay 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: CUFFS WERE LOSING AIR. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS: 3003898360-20 24-00417 AND 3003898360-2024-00419.

  Patient problems: Insufficient Information

  MAUDE report 19227899 ↗
• MalfunctionMay 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: CUFFS WERE LOSING AIR. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS: 3003898360-2024-00418 AND 3003898360-2024-00419.

  Patient problems: Insufficient Information

  MAUDE report 19227892 ↗
• MalfunctionOct 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "(4) 7.5 ETT'S WERE USED AND THE BALLOONS DEFLATED. PROVIDER AFTER FOUR ATTEMPTS THEN USED A SIZE 8.0 ETT WITH SUCCESS. THE CUSTOMER CLAIMS THAT THEY TESTED THE BALLOON PRIOR TO INFLATION (BY INFLATING IT TO SEE THAT IT WOULD HOLD AIR." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION, OR INJURY. THE CURRENT PATIENT STATUS IS UNKNOWN. PLEASE SEE ASSOCIATED MDRS #3003898360-2023-01408, 3003898360-2023-01409, 3003898360-2023-01393.

  Patient problems: Insufficient Information

  MAUDE report 17900501 ↗
• MalfunctionOct 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "(4) 7.5 ETT'S WERE USED AND THE BALLOONS DEFLATED. PROVIDER AFTER FOUR ATTEMPTS THEN USED A SIZE 8.0 ETT WITH SUCCESS. THE CUSTOMER CLAIMS THAT THEY TESTED THE BALLOON PRIOR TO INFLATION (BY INFLATING IT TO SEE THAT IT WOULD HOLD AIR." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION, OR INJURY. THE CURRENT PATIENT STATUS IS UNKNOWN. PLEASE SEE ASSOCIATED MDRS #3003898360-2023-01407, 3003898360-2023-01409, 3003898360-2023-01393.

  Patient problems: Insufficient Information

  MAUDE report 17900497 ↗
• MalfunctionOct 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "(4) 7.5 ETT'S WERE USED AND THE BALLOONS DEFLATED. PROVIDER AFTER FOUR ATTEMPTS THEN USED A SIZE 8.0 ETT WITH SUCCESS. THE CUSTOMER CLAIMS THAT THEY TESTED THE BALLOON PRIOR TO INFLATION (BY INFLATING IT TO SEE THAT IT WOULD HOLD AIR." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION, OR INJURY. THE CURRENT PATIENT STATUS IS UNKNOWN. ASSOCIATED MDRS #3003898360-2023-01407, 3003898360-2023-01408, 3003898360-2023-01393.

  Patient problems: Insufficient Information

  MAUDE report 17900489 ↗
• MalfunctionOct 3, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "(4) 7.5 ETT'S WERE USED AND THE BALLOONS DEFLATED. PROVIDER AFTER FOUR ATTEMPTS THEN USED A SIZE 8.0 ETT WITH SUCCESS. THE CUSTOMER CLAIMS THAT THEY TESTED THE BALLOON PRIOR TO INFLATION (BY INFLATING IT TO SEE THAT IT WOULD HOLD AIR." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION, OR INJURY. THE CURRENT PATIENT STATUS IS UNKNOWN. SEE ASSOCIATED MDR #3003898360-2023-01401, 3003898360-2023-01400, 3003898360-2023-01405.

  Patient problems: Insufficient Information

  MAUDE report 17863300 ↗
• MalfunctionOct 3, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "(4) 7.5 ETT'S WERE USED AND THE BALLOONS DEFLATED. PROVIDER AFTER FOUR ATTEMPTS THEN USED A SIZE 8.0 ETT WITH SUCCESS. THE CUSTOMER CLAIMS THAT THEY TESTED THE BALLOON PRIOR TO INFLATION (BY INFLATING IT TO SEE THAT IT WOULD HOLD AIR." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION, OR INJURY. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17863238 ↗
• MalfunctionSep 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTUBATION IT WAS FOUND THAT THE CUFF HAD A LEAK, "INTUBATION NOT DIFFICULT, PATIENT DID NOT DESATURATE". NO PATIENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS "UNKNOWN" AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795162 ↗
• MalfunctionAug 11, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THIS TUBE WAS USED BY [THE DOCTOR] IN THE OR (AND DIDN'T WORK). NO OTHER DETAILS WERE PROVIDED"

  Patient problems: Insufficient Information

  MAUDE report 17515233 ↗
• MalfunctionAug 2, 2023Disconnection; Disconnection

  IT IS REPORTED THAT ON AN INTUBATED PATIENT, THE "15MM HUB CONNECTOR COMING OUT MULTIPLE TIMES". THE ISSUE WAS RESOLVED AS "THEY JUST KEPT PUTTING IT BACK IN". THERE WAS NO PATIENT HARM, DESATURATION, OR INJURY. THE PATIENT DID NOT REQUIRE REINTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444427 ↗
• MalfunctionAug 2, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING "A CODE WE HAD MULTIPLE 7.5 ETTS FAIL TO SEAL AFTER INTUBATION. 4 ETT FAILED AFTER PLACEMENT IN THE PATIENT, BUT PASSED A LEAK TEST BEFORE INTUBATION. ONE ETT AFTER BEING REMOVED FROM THE PATIENT HAD THE CUFF LEAK SALINE AFTER TRYING TO CHECK THE INTEGRITY OF THE CUFF BALLOON." THE REPORT ALSO STATES, THE PATIENT HAD A LARGE NECK, TONGUE, AND A LARGER THAN NORMAL TRACH THAT MAY HAVE INTENSIFIED THE SITUATION. PATIENT DIDN'T DESATURATE. EACH AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3003898360-2023-01184, 3003898360-2023-01185, 3003898360-2023-01213.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440261 ↗
• MalfunctionAug 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING "A CODE WE HAD MULTIPLE 7.5 ETTS FAIL TO SEAL AFTER INTUBATION. 4 ETT FAILED AFTER PLACEMENT IN THE PATIENT, BUT PASSED A LEAK TEST BEFORE INTUBATION. ONE ETT AFTER BEING REMOVED FROM THE PATIENT HAD THE CUFF LEAK SALINE AFTER TRYING TO CHECK THE INTEGRITY OF THE CUFF BALLOON." THE REPORT ALSO STATES, THE PATIENT HAD A LARGE NECK, TONGUE, AND A LARGER THAN NORMAL TRACH THAT MAY HAVE INTENSIFIED THE SITUATION. PATIENT DIDN'T DESATURATE. EACH AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3003898360-2023-01183, 3003898360-2023-01185, 3003898360-2023-01213.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436667 ↗
• MalfunctionAug 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING "A CODE WE HAD MULTIPLE 7.5 ETTS FAIL TO SEAL AFTER INTUBATION. 4 ETT FAILED AFTER PLACEMENT IN THE PATIENT, BUT PASSED A LEAK TEST BEFORE INTUBATION. ONE ETT AFTER BEING REMOVED FROM THE PATIENT HAD THE CUFF LEAK SALINE AFTER TRYING TO CHECK THE INTEGRITY OF THE CUFF BALLOON." THE REPORT ALSO STATES, THE PATIENT HAD A LARGE NECK, TONGUE, AND A LARGER THAN NORMAL TRACH THAT MAY HAVE INTENSIFIED THE SITUATION. PATIENT DIDN'T DESATURATE. EACH AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3003898360-2023-01183, 3003898360-2023-01184, 3003898360-2023-01213.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436651 ↗
• MalfunctionAug 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING "A CODE WE HAD MULTIPLE 7.5 ETTS FAIL TO SEAL AFTER INTUBATION. 4 ETT FAILED AFTER PLACEMENT IN THE PATIENT, BUT PASSED A LEAK TEST BEFORE INTUBATION. ONE ETT AFTER BEING REMOVED FROM THE PATIENT HAD THE CUFF LEAK SALINE AFTER TRYING TO CHECK THE INTEGRITY OF THE CUFF BALLOON." THE REPORT ALSO STATES, THE PATIENT HAD A LARGE NECK, TONGUE, AND A LARGER THAN NORMAL TRACH THAT MAY HAVE INTENSIFIED THE SITUATION. PATIENT DIDN'T DESATURATE. EACH AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3003898360-2023-01183, 3003898360-2023-01184, 3003898360-2023-01185.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436591 ↗

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-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-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-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-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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• 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-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-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-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-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-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.