The FDA has posted 7 enforcement recalls of breathing-circuit bacterial filter devices since 2025, including 5 Class I (most serious) recalls. Most recent report: Nov 19, 2025.
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 ag…
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manu…
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manu…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Filter, Bacterial, Breathing-Circuit”). Informational only — verify against the FDA before acting.