CAPNOCHECK BCI Airway Adapter — Class II medical device recall Z-1404-2025
Ongoing recall by Smiths Medical ASD, Inc., reported 2025-03-26, distributed nationwide. Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure ma
| Recall number | Z-1404-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Minneapolis, MN, United States |
| Recall initiated | 2025-02-14 |
| Classified | 2025-03-20 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 35019517062667 |
| Lot numbers | 2367264, 2373071, 2658411, 2690517, 2695046, 2792606, 2823742, 2843746, 2898265, 2899311, 2929198, 2943659, 2950547, 2959836, 2978300, 2983686, 2986391, 3000742, 3027404, 3048157, 3057565, 3078619, 3097350, 3109127, 3123384, 3145330, 3159020, 3168379, 3172848, 3172849, 3190273, 3214132, 3227502, 3230971, 3243790, 3249030, 3255107, 3258815, 3267952, 3272253 and 205 more |
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1404-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.