Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1405-2025 — CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

U.S. FDA — Device Enforcement · United States · 2025-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1405-2025
Date of alert
2025-02-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30610586038444
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.