Portex H4022SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315077586), received between Nov 13, 2017 and May 20, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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 16, 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.

• 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 11860017 ↗
• 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 11860015 ↗
• 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 11859857 ↗
• InjuryDec 4, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WAS ELECTIVELY RE-INTUBATED WITH A 3.5 MM SMITHS MEDICAL PORTEX® UNCUFFED NEONATAL/PEDIATRIC ENDOTRACHEAL TUBE WHEN THE PACKAGING STATED 3.0 MM. IT WAS REPORTED THAT THE PHYSICIAN WOULD HAVE PREFERRED 3.0 MM SIZE BUT THE PATIENT BECAME "STRESSED" AFTER INSERTION OF THE LARGER ENDOTRACHEAL TUBE (ETT). NO CHANGE OUT TO THE CORRECT SIZE WAS PERFORMED DUE TO THE STATUS OF THE PATIENT BEING "STRESSED" WITH REPORTED CLINICAL INJURY PER PHYSICIAN. THIS COMPLAINT WILL BE REPORTED AS SERIOUS INJURY DUE TO THE REPORTED SERIOUS INJURY. THE AVAILABLE INFORMATION SUGGESTS THAT THE SMITHS MEDICAL PRODUCT COULD HAVE LED TO A LIFE-THREATENING INJURY / ILLNESS.

  Patient problems: Respiratory Distress

  MAUDE report 7079214 ↗
• MalfunctionNov 13, 2017Device Markings/Labelling Problem

  A BABY WAS ELECTIVELY RE-INTUBATED BY PHYSICIAN. PICKED UP AN UNOPENED ETT THAT SAID IT WAS A 3.0 AND IT WAS PLACED INTO THE BABY'S TRACHEA. UPON FURTHER EXAMINATION, THE ETT WAS ACTUALLY A 3.5. IT WAS PACKAGED IN A 3.0, SEALED FROM THE FACTORY, PACKAGE. PHYSICIAN WOULD NOT PUT THE SMALLER ETT IN THE TRACHEA AS THE BABY HAD BEEN STRESSED OUT ENOUGH FOR THE MOMENT. UNOPENED PACKAGE MARKED 3.0 ET BUT ACTUALLY HELD A 3.5 ET. IT WAS NOTICED AFTER THE BABY WAS INTUBATED. RT SUPERVISOR WENT THROUGH ALL OF OUR CURRENT STOCK OF ET TUBES AND DID NOT FIND ANY OTHER MISMARKED PACKAGES.

  Patient problems: No Information

  MAUDE report 7024670 ↗

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-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-2539-2014 · Jul 7, 2014 · Terminated
  H4002S Neonatal/Paed.Intubation Kit 3.0mm 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