CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a risk-of-harm medical device (FDA Class II airway adapter that may break during use) where injury has not been explicitly reported in the source. The potential consequences—airway circuit failure, hypoxia, and cardiopulmonary collapse—are serious, meeting the High severity criterion for risk-of-harm products without reported injuries.
Plain-English summary
The CAPNOCHECK BCI Airway Adapter (Model Number BSR, Product Code WW1100), manufactured by Smiths Medical ASD, Inc., is being recalled by the FDA.
The 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 the airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Approximately 175,994 units were distributed nationwide in the United States, with additional units distributed internationally. The specific affected lot numbers are identified in the FDA recall notice.
The recalled product
- Product
- CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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