SHERIDAN IPN931410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704941114), received between Jan 30, 2026 and Sep 1, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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 1, 2026Disconnection

  Patient problems: Low Oxygen Saturation

  MAUDE report 50534433 ↗
• MalfunctionAug 31, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533791 ↗
• MalfunctionJul 14, 2026Leak/Splash

  IT WAS REPORTED THAT "CCU 1 WAS INITIALLY INTUBATED ON JUNE 12 AT 23:27 WITH AN 8.0 ETT. PATIENT SELF-EXTUBATED ON JUNE 13 AT 00:24 AND WAS REINTUBATED BY MD AND PA WITH A 2ND 8.0 ETT. MD NOTICED THAT THE BALLOON WAS DEFLATING WITHIN 30 SECONDS, AND AN AUDIBLE LEAK WAS HEARD. WE OPENED A 7.5 ETT, AND IT WAS SAFELY EXCHANGED WITH A BOUGIE AFTER CHECKING PATENCY. THE TEAM THAT WAS PRESENT DURING BOTH INTUBATIONS DEBRIEFED AND CONFIRMED THAT BOTH ETTS WERE CHECKED FOR PATENCY AND CUFF INTEGRITY PRIOR TO PLACEMENT. FOLLOWING PHYSICAL ASSESSMENT OF THE 1ST AND 2ND ETTS, IT WAS NOTED THAT BOTH CUFFS EXHIBITED A SLOW AIR LEAK, RESULTING IN GRADUAL CUFF DEFLATION." ADDITIONAL INFORMATION RECEIVED ON JUNE 30, 2026, INDICATED THAT "THE PATIENT HAD DESATURATED 10-20%." TWO DEVICES INVOLVED. ASSOCIATED MDRS: 3003898360-2026-00304 AND 3003898360-2026-00303.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25814622 ↗
• InjuryJul 14, 2026Leak/Splash

  IT WAS REPORTED THAT "CCU 1 WAS INITIALLY INTUBATED ON (B)(6) AT 23:27 WITH AN 8.0 ETT. PATIENT SELF-EXTUBATED ON (B)(6) AT 00:24 AND WAS REINTUBATED BY MD AND PA WITH A 2ND 8.0 ETT. MD NOTICED THAT THE BALLOON WAS DEFLATING WITHIN 30 SECONDS, AND AN AUDIBLE LEAK WAS HEARD. WE OPENED A 7.5 ETT, AND IT WAS SAFELY EXCHANGED WITH A BOUGIE AFTER CHECKING PATENCY. THE TEAM THAT WAS PRESENT DURING BOTH INTUBATIONS DEBRIEFED AND CONFIRMED THAT BOTH ETTS WERE CHECKED FOR PATENCY AND CUFF INTEGRITY PRIOR TO PLACEMENT. FOLLOWING PHYSICAL ASSESSMENT OF THE 1ST AND 2ND ETTS, IT WAS NOTED THAT BOTH CUFFS EXHIBITED A SLOW AIR LEAK, RESULTING IN GRADUAL CUFF DEFLATION." ADDITIONAL INFORMATION RECEIVED ON JUNE 30, 2026, INDICATED THAT "THE PATIENT HAD DESATURATED 10-20%." TWO DEVICES INVOLVED. ASSOCIATED MDRS: 3003898360-2026-00304.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25814592 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT: "THE CLEAR TIP KEEPS DISCONNECTING FROM THE TUBE. IT DOESN'T SEEM TIGHT ENOUGH TO STAY IN PLACE. THE PROBLEM IS THE SAME FOR BOTH THE 7MM AND 8MM SIZES AT THE MOMENT." ASSOCIATED COMPLAINTS 3003898360-2026-00055. .

  Patient problems: Insufficient Information

  MAUDE report 24223092 ↗

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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 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-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-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-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-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-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-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• 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

…and 12 more.