Medline Industries, Inc. DYNJAA10641Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10889942841226), received between Nov 5, 2025 and Nov 6, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

• InjuryNov 6, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, "THE ANESTHESIA CIRCUITS APPEAR TO BE EITHER CUT OR DAMAGED" CAUSING THE "MACHINES TO ALARM WITH A PRESSURE LEAK". THE CUSTOMER DID NOT REPORT ANY PATIENT IMPACT OR ADVERSE HEALTH EFFECT RELATED TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491190 ↗
• InjuryNov 6, 2025Crack; Gas/Air Leak; Crack; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, THE TUBING "CRACKED" AND "LEAKED DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487695 ↗
• InjuryNov 6, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, "THE ANESTHESIA CIRCUITS APPEAR TO BE EITHER CUT OR DAMAGED" CAUSING THE "MACHINES TO ALARM WITH A PRESSURE LEAK". THE CUSTOMER DID NOT REPORT ANY PATIENT IMPACT OR ADVERSE HEALTH EFFECT RELATED TO THE REPORTED ISSUE. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486268 ↗
• InjuryNov 6, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, THE TUBING "CRACKED" AND "LEAKED DURING USE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486263 ↗
• InjuryNov 5, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ANESTHESIA CIRCUIT APPEARED CUT OR DAMAGED, TRIGGERING MACHINE ALARMS FOR PRESSURE LEAKS UPON PATIENT CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478438 ↗