MEDLINE INDUSTRIES, INC. DYNJAA10685BRecalls & reported problems
Medline Industries, Inc. · ANESTHESIA CIRCUIT-LF · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10198459372292), received between Oct 31, 2025 and Sep 22, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Crack3
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Crack
It was reported that "BH2 OR General Anesthesia circuit-LF- broken off at the end near the filter." "There were 2 circuits of this same lot that were found defective."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853358 ↗MalfunctionJan 23, 2026Crack
InjuryOct 31, 2025Break; Crack; Material Integrity Problem; Break; Crack; Material Integrity Problem
ACCORDING TO THE FACILITY, "TUBING BREAKING DURING USE. IT'S PASSING THE HIGH-PRESSURE LEAK TEST- BUT WHEN THEY GO TO EXTEND THE CORRUGATED PART OF THE CIRCUIT IT'S CRACKING.".
Patient problems: Insufficient Information
MAUDE report 23442102 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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