FDA Device Intelligence
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Filter, Bacterial, Breathing-Circuit

FDA product code CAH · Class 2 · Anesthesiology

2,883
Registered devices
1,004
Adverse events
28
Recalls
202
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-10-10Medline Industries, LPFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypov
2025-06-16Draeger, Inc.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-06-16Draeger, Inc.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-06-16Draeger, Inc.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-06-16Draeger, Inc.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-01-09Kung Shin Plastics Co. Ltd.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 whic
2025-01-09Kung Shin Plastics Co. Ltd.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 whic
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2023-07-18Smiths Medical ASD Inc.Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
2023-01-05S & MOHR AMERICA, S.A. DE C.V.Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.