Class II

Medical Device Recall: CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Smiths Medical ASD, Inc. · February 14, 2025

Reason for Recall

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

Distribution

US Nationwide distribution. International distribution pending.

States Affected

NATIONWIDE

Quantity Affected

175,994 US; 45,223 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1405-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.