Filter, Bacterial, Breathing-Circuit
FDA adverse event reports and recall history for filter, bacterial, breathing-circuit (product code CAH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 998
- Deaths
- 41
- Injuries
- 190
- Malfunctions
- 728
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-11-13Open, ClassifiedNonconforming Material/Component
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
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.
- 2025-07-31Open, ClassifiedProcess control
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- 2025-07-31Open, ClassifiedProcess control
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- 2025-07-31Open, ClassifiedProcess control
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- 2025-07-31Open, ClassifiedProcess control
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- 2025-03-04Open, ClassifiedProcess design
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
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 manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
- 2025-03-04Open, ClassifiedProcess design
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
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 manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
- 2024-09-06Open, ClassifiedUnder Investigation by firm
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- 2023-08-28Open, ClassifiedDevice Design
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
- 2023-02-22Open, ClassifiedProcess control
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089
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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