Portex 100/126/025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315056758), received between Oct 31, 2017 and Jul 16, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25840750 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT THE TUBE BROKE OFF NEAR THE HUB AFTER TRYING TO LOOSEN THE BLUE HUB FROM THE TUBE. NO PATIENT INJURY.

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

  MAUDE report 12450531 ↗
• MalfunctionJan 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE CUSTOMER REPORTED THE FOLLOWING PRODUCT PROBLEM. THE ISSUE WAS RELATED TO THE ENDOTRACHEAL TUBES NOT ALL BEING THE SAME LENGTH. THE CUSTOMER NOTICED THAT THEY WERE CUT AT DIFFERENT POSITIONS WHICH CAUSED THE INLINE SUCTION CATHETERS TO NOT BE INSERTED TO THE DESIRED DEPTH. THE CUSTOMER BELIEVED THAT IT WAS NOT A TRUE PRODUCT FAILURE, AS THE ENDOTRACHEAL TUBE STILL PROVIDED A PATENT AIRWAY TO THE PATIENT FOR INTUBATION. THE CUSTOMER NOTED THAT IT WAS JUST NOT A STANDARD CUT WHERE THE TUBE WAS ATTACHED TO THE HUB OF THE CONNECTOR. THE CUSTOMER ADJUSTED THE POSITION OF THE INLINE SUCTION CATHETER INSERTION SO THAT THEY COULD CLEAR THE PATIENT'S AIRWAY, AND HAVE THE CATHETER GO TO THE PROPER DEPTH. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593817 ↗
• MalfunctionJan 15, 2020Component Incompatible; Inadequacy of Device Shape and/or Size; Component Incompatible; Inadequacy of Device Shape and/or Size

  THE CUSTOMER REPORTED THE FOLLOWING PRODUCT PROBLEM. THE ISSUE WAS RELATED TO THE ENDOTRACHEAL TUBES NOT ALL BEING THE SAME LENGTH. THE CUSTOMER NOTICED THAT THEY WERE CUT AT DIFFERENT POSITIONS WHICH CAUSED THE INLINE SUCTION CATHETERS TO NOT BE INSERTED TO THE DESIRED DEPTH. THE CUSTOMER BELIEVED THAT IT WAS NOT A TRUE PRODUCT FAILURE, AS THE ENDOTRACHEAL TUBE STILL PROVIDED A PATENT AIRWAY TO THE PATIENT FOR INTUBATION. THE CUSTOMER NOTED THAT IT WAS JUST NOT A STANDARD CUT WHERE THE TUBE WAS ATTACHED TO THE HUB OF THE CONNECTOR. THE CUSTOMER ADJUSTED THE POSITION OF THE INLINE SUCTION CATHETER INSERTION SO THAT THEY COULD CLEAR THE PATIENT'S AIRWAY, AND HAVE THE CATHETER GO TO THE PROPER DEPTH. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9593787 ↗
• InjuryOct 31, 2017Separation Failure; Separation Failure

  IT WAS REPORTED THAT A SMITHS MEDICAL CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE ADAPTER WAS REQUIRED TO BE REMOVED WITH CONSIDERABLE EFFORT OR WAS CUT OFF IN ORDER TO PLACE IN-LINE SUCTION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6991240 ↗

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-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm 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-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