HUDSON RCI IPN048904Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704616838), received between Apr 5, 2021 and Apr 5, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MAUDE COMPLAINT: SHERIDAN (ENDOTRACHEAL TUBE) ETT HUB ADAPTORS ARE EXTREMELY LOOSE AND SLIP OFF TOO EASILY. SHERIDAN ETT TUBE HUB ADAPTOR CAME LOOSE 6-8 TIMES DURING CODE EVENT AND CAME OFF THE TOP OF THE ETT WHILE BAGGING. PATIENT BEING EMERGENTLY INTUBATED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION DURING CODE EVENT. DURING CODE EVENT, MD DECIDED TO INTUBATE WITH 3. 5 CUFFED ETT (SHERIDAN) FROM YELLOW AIRWAY CODE CART. RESPIRATORY CARE PRACTINIONER (RCP) WAS BAGGING THE PATIENT AND WAS NOT PART OF PREPARING ETT IN EMERGENT INTUBATION. A 3. 5 SHERIDAN WAS INSERTED INTO THE AIRWAY WITHOUT A REQUIRED ETT HUB ADAPTER. MD ACKNOWLEDGED ERROR AND EXTUBATED PATIENT, REINTUBATED WITH PROPER 3. 5 ETT. DURING BAGGING AND CODE COMPRESSIONS, SHERIDAN ETT TUBE HUB ADAPTOR CAME LOOSE 6-8 TIMES DURING CODE EVENT AND CAME OFF THE TOP OF THE ETT WHILE BAGGING AND HIGH PRESSURES AND PEEP. SIGNIFICANT EFFORT TAKEN BY MD AND RCP AT HEAD OF BED TO KEEP AIRWAY INTACT DURING CODE EVENT. SHERIDAN MANUFACTURED ETT HUB ADAPTER ALREADY SEPARATED FROM THE ETT IN PACKAGE AND ON OPPOSITE SIDE OF THE PACKAGE AND EASILY LOST WHEN OPNENED. REPLACE SHERIDAN ETT WITH ANOTHER MANUFACTURER OR SEEK OUT

  Patient problems: Respiratory Insufficiency

  MAUDE report 11616302 ↗
• InjuryApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MAUDE COMPLAINT: SHERIDAN (ENDOTRACHEAL TUBE) ETT HUB ADAPTORS ARE EXTREMELY LOOSE AND SLIP OFF TOO EASILY. SHERIDAN ETT TUBE HUB ADAPTOR CAME LOOSE 6-8 TIMES DURING CODE EVENT AND CAME OFF THE TOP OF THE ETT WHILE BAGGING. PATIENT BEING EMERGENTLY INTUBATED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION DURING CODE EVENT. DURING CODE EVENT, MD DECIDED TO INTUBATE WITH 3. 5 CUFFED ETT (SHERIDAN) FROM YELLOW AIRWAY CODE CART. RESPIRATORY CARE PRACTINIONER (RCP) WAS BAGGING THE PATIENT AND WAS NOT PART OF PREPARING ETT IN EMERGENT INTUBATION. A 3. 5 SHERIDAN WAS INSERTED INTO THE AIRWAY WITHOUT A REQUIRED ETT HUB ADAPTER. MD ACKNOWLEDGED ERROR AND EXTUBATED PATIENT, REINTUBATED WITH PROPER 3. 5 ETT. DURING BAGGING AND CODE COMPRESSIONS, SHERIDAN ETT TUBE HUB ADAPTOR CAME LOOSE 6-8 TIMES DURING CODE EVENT AND CAME OFF THE TOP OF THE ETT WHILE BAGGING AND HIGH PRESSURES AND PEEP. SIGNIFICANT EFFORT TAKEN BY MD AND RCP AT HEAD OF BED TO KEEP AIRWAY INTACT DURING CODE EVENT. SHERIDAN MANUFACTURED ETT HUB ADAPTER ALREADY SEPARATED FROM THE ETT IN PACKAGE AND ON OPPOSITE SIDE OF THE PACKAGE AND EASILY LOST WHEN OPNENED. REPLACE SHERIDAN ETT WITH ANOTHER MANUFACTURER OR SEEK OUT

  Patient problems: Respiratory Insufficiency

  MAUDE report 11616279 ↗

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-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-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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• Z-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• 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-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-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-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-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.