Medline Industries, Inc. DYNJAA0380ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10195327478285), received between Aug 27, 2025 and Aug 28, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 reports).

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

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. Oct 10, 2025Class IOpen, Classified

   Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

   Z-0442-2026 · Root cause: Nonconforming Material/Component · 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.

• InjuryAug 28, 2025Fracture; Fracture

  ACCORDING TO THE FACILITY, THERE ARE "CRACKS IN THE CIRCUIT AFTER BEING ATTACHED TO A PATIENT, FOLLOWING SUCCESSFUL PASSING OF SAFETY CHECK AND PATIENT INDUCTION. ANESTHESIA MACHINE NOTIFIES OF CIRCUIT LEAK AND EXTREME REDUCTION IN ABILITY TO VENTILATE PATIENT." PER THE FACILITY, "CIRCUIT IS IMMEDIATELY REPLACED. NO MAJOR HARM, HOWEVER PATIENTS HAD REDUCED OXYGENATION DUE TO EXTREME REDUCTION IN ABILITY TO VENTILATE." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Hypoventilation

  MAUDE report 22912450 ↗
• InjuryAug 28, 2025Fracture; Fracture

  ACCORDING TO THE FACILITY, THERE ARE "CRACKS IN THE CIRCUIT AFTER BEING ATTACHED TO A PATIENT, FOLLOWING SUCCESSFUL PASSING OF SAFETY CHECK AND PATIENT INDUCTION. ANESTHESIA MACHINE NOTIFIES OF CIRCUIT LEAK AND EXTREME REDUCTION IN ABILITY TO VENTILATE PATIENT." PER THE FACILITY, "CIRCUIT IS IMMEDIATELY REPLACED. NO MAJOR HARM, HOWEVER PATIENTS HAD REDUCED OXYGENATION DUE TO EXTREME REDUCTION IN ABILITY TO VENTILATE."

  Patient problems: Hypoventilation; Ventilator Dependent

  MAUDE report 22912305 ↗
• InjuryAug 27, 2025Fracture; Fracture

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, THERE ARE "CRACKS IN THE CIRCUIT AFTER BEING ATTACHED TO A PATIENT, FOLLOWING SUCCESSFUL PASSING OF SAFETY CHECK AND PATIENT INDUCTION. ANESTHESIA MACHINE NOTIFIES OF CIRCUIT LEAK AND EXTREME REDUCTION IN ABILITY TO VENTILATE PATIENT." PER THE FACILITY, "CIRCUIT IS IMMEDIATELY REPLACED. NO MAJOR HARM, HOWEVER PATIENTS HAD REDUCED OXYGENATION DUE TO EXTREME REDUCTION IN ABILITY TO VENTILATE."

  Patient problems: Hypoventilation; Ventilator Dependent

  MAUDE report 22909236 ↗
• InjuryAug 27, 2025Fracture; Fracture

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, THERE ARE "CRACKS IN THE CIRCUIT AFTER BEING ATTACHED TO A PATIENT, FOLLOWING SUCCESSFUL PASSING OF SAFETY CHECK AND PATIENT INDUCTION. ANESTHESIA MACHINE NOTIFIES OF CIRCUIT LEAK AND EXTREME REDUCTION IN ABILITY TO VENTILATE PATIENT." PER THE FACILITY, "CIRCUIT IS IMMEDIATELY REPLACED. NO MAJOR HARM, HOWEVER PATIENTS HAD REDUCED OXYGENATION DUE TO EXTREME REDUCTION IN ABILITY TO VENTILATE."

  Patient problems: Hypoventilation; Ventilator Dependent

  MAUDE report 22907551 ↗
• InjuryAug 27, 2025Fracture; Fracture

  ACCORDING TO THE FACILITY, THERE ARE "CRACKS IN THE CIRCUIT AFTER BEING ATTACHED TO A PATIENT, FOLLOWING SUCCESSFUL PASSING OF SAFETY CHECK AND PATIENT INDUCTION. ANESTHESIA MACHINE NOTIFIES OF CIRCUIT LEAK AND EXTREME REDUCTION IN ABILITY TO VENTILATE PATIENT." PER THE FACILITY, "CIRCUIT IS IMMEDIATELY REPLACED. NO MAJOR HARM, HOWEVER PATIENTS HAD REDUCED OXYGENATION DUE TO EXTREME REDUCTION IN ABILITY TO VENTILATE."

  Patient problems: Hypoventilation; Ventilator Dependent

  MAUDE report 22903692 ↗