Portex 100/111/030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315018855), received between Apr 28, 2021 and Jan 6, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT A LARGE ENDOTRACHEAL TUBE LEAK WAS IDENTIFIED, RESULTING IN DIFFICULTY MANAGING VENTILATION. THE BIOMEDICAL TECHNICIAN USED CALIPERS TO MEASURE THE OUTER DIAMETER AT MULTIPLE LOCATIONS, AND ALL MEASUREMENTS WERE FOUND TO BE SMALLER THAN EXPECTED FOR THIS ITEM. THE PATIENT EXPERIENCED MINIMAL HARM AND REQUIRED PROLONGED CARE. A NEW TRACHEAL TUBE WAS REQUIRED DUE TO DIFFICULTY MANAGING VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976065 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT A LARGE ENDOTRACHEAL TUBE LEAK WAS IDENTIFIED, RESULTING IN DIFFICULTY MANAGING VENTILATION. AT THE TIME OF REPORTING THE TUBE REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975783 ↗
• MalfunctionMay 7, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IT IS A CASE WHERE AN AVANOS CLOSED SUCTION CATHETER (8FG 2.7 MM) WAS USED ON A PATIENT, RESISTANCE (STRONG STICKING) OCCURRED WHEN THE CATHETER WAS ADVANCED ABOUT 8 CM, AND THE USE OF THE CLOSED CATHETER WAS DISCONTINUED AS THIS HAD NEVER HAPPENED BEFORE. THERE WAS NO REINTUBATION. AT THIS TIME, THE CLOSED CATHETER WAS SUSPECTED, AND THE COMPLAINT PRODUCT WAS SENT TO AVANOS FOR ANALYSIS. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978788 ↗
• InjuryOct 2, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE "BABY IN OHF MODE NO LONGER VIBRATES ACCORDING TO ITS POSITION". THE NURSE WAS FORCED TO HYPEREXTEND, WITH THE INTUBATION TUBE PULLED UPWARDS AND TO MODIFY ITS POSITION CONSTANTLY SO THAT THE CHILD COULD BE VENTILATED. THIS RESULTED IN AN INCREASE IN DEMAND DEPENDING ON THE CHILD'S POSITION. CLINICAL CONSEQUENCES AS DESATURATION, BRADYCARDIA, INCREASED OXYGEN REQUIREMENTS WERE REPORTED AND THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 17855487 ↗
• MalfunctionSep 17, 2021Unsealed Device Packaging; Unsealed Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT UPON OPENING OF A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE, IT WAS NOTED THAT THE PACKAGE WAS NOT COMPLETELY SEALED. NO PATIENT WAS INVOLVED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488359 ↗
• 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 11741614 ↗

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-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-2538-2014 · Jul 7, 2014 · Terminated
  H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn 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-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