Portex 100/111/035Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315018862), received between Jan 4, 2019 and Apr 28, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 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.

Recalls naming this device

1. Feb 13, 2025Class IOpen, Classified

   Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

   Z-1289-2025 · Root cause: Process change control · Recall details · FDA record ↗

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.

• InjuryApr 28, 2021Connection Problem; Connection Problem

  ADDITIONAL INFORMATION: THERE WAS NO ADVERSE OUTCOME AS THE PATIENT WAS SUCCESSFULLY RE-INTUBATED AND FULLY RELEASING THE CLIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742012 ↗
• MalfunctionJul 1, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE CUFF OF A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS FOUND TO BE STUCK. IT COULD NOT BE REMOVED, AND THE CUFF HAD TO BE CUT TO FIX SUCTION LINE AND VENTILATE.

  Patient problems: No Information

  MAUDE report 8749764 ↗
• InjuryJan 28, 2019Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED THAT THE BLUE ADAPTOR OF A SMITHS MEDICAL PORTEX SILICONISED PVC, ORAL/NASAL UNCUFFED TRACHEAL TUBE WAS DIFFICULT TO REMOVE. THE ADAPTER IS NOTED TO BE REMOVED IN ORDER TO REDUCE THE DEAD SPACE IN THE TUBE POST INTUBATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282092 ↗
• MalfunctionJan 4, 2019Output Problem; Output Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS FOUND TO BE STUK AND COULD NOT BE REMOVED. THE CUFF HAD TO BE CUT FROM THE ET TUBE IN ORDER TO FIX THE INLINE SUCTION AND VENTILATE THIS WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219773 ↗
• MalfunctionJan 4, 2019Output Problem; Output Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS FOUND TO BE STUCK AND COULD NOT BE REMOVED. THE CUFF HAD TO BE CUT FROM THE ET TUBE IN ORDER TO FIX THE INLINE SUCTION AND VENTILATE THIS WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219758 ↗

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-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-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-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