Portex 100/111/020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315018831), received between May 16, 2025 and May 16, 2025 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN PRETERM INFANT REQUIRED INTUBATION FOR ONGOING RESPIRATORY MANAGEMENT. DURING A PLANNED UPSIZING OF THE ENDOTRACHEAL (ET) TUBE, THE INFANT HAD A 3RD EPISODE OF A TYPICAL INTUBATION FINDING AND REQUIRED USE OF A RECALLED SIZE 2.0 ET TUBE. THE TUBE WAS USED IN THE KNOWLEDGE THAT IT HAD BEEN RECALLED BUT WAS USED AS A LIFESAVING INTERVENTION. THE INFANT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER NEONATAL UNIT FOR EAR, NOSE, AND THROAT (ENT) REVIEW, AND THE ET TUBE WAS STRAIGHTFORWARD, AND A SUCTION CATHETER COULD BE PASSED THROUGH THE ET TUBE TO PROVIDE ET SUCTION. THE INFANT HAD A SIZE 2.0 ENT TUBE INSERTED IN THE EARLY HOURS ON (B)(6) 2025, (B)(6) 2025 AS AN EMERGENCY PROCEDURE PRIOR TO THE ABOVE INTUBATION. IT WAS REPORTED TO BE UNKNOWN WHAT BRAND OF ENT TUBE THAT WAS, AND IT WAS NOT POSSIBLE TO A SUCTION CATHETER VIA THAT ET TUBE. THE INFANT HAD BILATERAL GRADE 4 INTRAVENTRICULAR HEMORRHAGES (IVHS) WITH EARLY HYDROCEPHALUS EVIDENT ON SCAN. CARE WAS RE-ORIENTED ON (B)(6) 2025, AND THE INFANT DIED.

  Patient problems: Hydrocephalus; Intracranial Hemorrhage

  MAUDE report 22035626 ↗

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-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