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.

Smiths Medical ASD, Inc. Medical Device Recall: CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 | SafeCheck