CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Recall Insight

This FDA Devices action (record #Z-1404-2025) was formally reported on March 26, 2025, with the manufacturer initiating the action on February 14, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Smiths Medical ASD, Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 175,994 US; 45,223 OUS units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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 ci… Distribution data in the federal record shows the product reached: US Nationwide distribution. International distribution pending.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.