Portex 100/127/030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315019814), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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.

• MalfunctionNov 22, 2023Complete Blockage; Material Deformation; Complete Blockage; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH THE PRODUCT. THE "8FR" INLINE SUCTION CATHETER COULD NOT PASS THROUGH THE TUBE. AFTER DISCOVERING THE PROBLEM, NICU REPLACED THE CATHETER IT WITH A "7FR" CATHETER WITH "NO ISSUES". FURTHER INVESTIGATION REVEALED THAT THE AFFECTED ETT HAD A FLAT SIDE. ADVERSE EFFECTS WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193642 ↗

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-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-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