Portex H4003SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610674800119), received between May 20, 2021 and May 20, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K790312); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE REPORTED THE SMALL WHITE SCREW ON CAP AT THE SIDE OF THE ET TUBE WAS NOT REMOVED BY A STAFF AND THE FIRST INSTANCE INVOLVED A WHOLE NEW VENTILATION CIRCUIT BEING USED, STAFF COULD NOT IDENTIFY WHY THE CIRCUIT WAS NOT WORKING. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860014 ↗
• MalfunctionMay 20, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE REPORTED THE SMALL WHITE SCREW ON CAP AT THE SIDE OF THE ET TUBE WAS NOT REMOVED BY A STAFF AND THE FIRST INSTANCE INVOLVED A WHOLE NEW VENTILATION CIRCUIT BEING USED, STAFF COULD NOT IDENTIFY WHY THE CIRCUIT WAS NOT WORKING. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860013 ↗
• MalfunctionMay 20, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE REPORTED THE SMALL WHITE SCREW ON CAP AT THE SIDE OF THE ET TUBE WAS NOT REMOVED BY A STAFF AND THE FIRST INSTANCE INVOLVED A WHOLE NEW VENTILATION CIRCUIT BEING USED, STAFF COULD NOT IDENTIFY WHY THE CIRCUIT WAS NOT WORKING. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859942 ↗
• MalfunctionMay 20, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE REPORTED THE SMALL WHITE SCREW ON CAP AT THE SIDE OF THE ET TUBE WAS NOT REMOVED BY A STAFF AND THE FIRST INSTANCE INVOLVED A WHOLE NEW VENTILATION CIRCUIT BEING USED, STAFF COULD NOT IDENTIFY WHY THE CIRCUIT WAS NOT WORKING. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K790312. One submission often covers many models, so check the product and lot details in each record.

• Z-1289-2025 · Feb 13, 2025 · Open, Classified
  Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025
• Z-2539-2014 · Jul 7, 2014 · Terminated
  H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-2536-2014 · Jul 7, 2014 · Terminated
  4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
• Z-2538-2014 · Jul 7, 2014 · Terminated
  H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
• Z-1641-2014 · Apr 10, 2014 · Terminated
  Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space con