The Recall Desk
HighFDA (Devices)·Z-1405-2025·Announced 2025-03-26

CAPNOCHECK Airway Adapter May Break Off, Risking Ventilation Loss

CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for serious patient harm (ventilation loss, hypoxia, cardiopulmonary collapse) but no reported injuries or deaths. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the CAPNOCHECK BCI Airway Adapter (Model Number BSR, Product Code WW8214) due to a manufacturing defect. The adapter does not meet specification and may break off when a valve or tube is attached during use.

Device failure may result in inaccurate readings, a break in the airway circuit, and loss of ventilation. A disconnected airway circuit could prevent proper ventilation of a patient, potentially leading to inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

The recall affects approximately 175,994 units distributed nationwide in the United States and 45,223 units distributed internationally. Healthcare facilities using this product should stop use immediately and contact Smiths Medical ASD, Inc. for instructions on returning or replacing affected adapters.

The recalled product

Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Airway / Ventilation
Hazard
  • device-failure
  • airway-disconnect
  • ventilation-loss

Distribution

Distributed nationwide across the United States.

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