CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Device Recall #Z-1405-2025 — Class II — February 14, 2025
Recall Summary
| Recall Number | Z-1405-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 14, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smiths Medical ASD, Inc. |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 175,994 US; 45,223 OUS |
Product Description
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
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.
Distribution Pattern
US Nationwide distribution. International distribution pending.
Lot / Code Information
UDI-DI 30610586038444 Lots WW8214 022980-1-22 022404-1-17 021860-1-10 021110-1-7 020609-1-2 016288-1-1 022980-1-24 022404-1-18 021860-1-14 021110-1-8 020609-1-3 017774-1-1 022980-1-23 022404-1-19 021860-1-13 021110-1-9 020609-1-4 018139-1-1 022980-1-26 022404-1-20 021860-1-15 021110-1-10 020609-1-5 018184-1-1 022980-1-27 022404-1-21 021860-1-17 021110-1-11 020609-1-6 018252-1-1 022980-1-28 022404-1-22 021860-1-16 021110-1-12 020609-1-7 018458-1-1 022980-1-25 022404-1-23 021860-1-18 021110-1-13 020609-1-8 018457-1-1 022980-1-32 022404-1-24 021860-1-20 021110-1-14 020609-1-9 018614-1-1 022980-1-30 022404-1-25 021860-1-21 021110-1-16 020609-1-10 018641-1-1 022980-1-29 022404-1-26 021860-1-19 021110-1-15 020609-1-11 018789-1-1 022980-1-31 022404-2-2 021860-2-1 021110-1-17 020609-1-12 018789-2-1 022980-1-33 022404-1-27 021860-2-2 021110-1-18 020609-1-13 018789-3-1 023592-1-3 022404-2-1 021860-1-22 021110-1-19 020609-1-14 018789-4-1 023592-1-2 022404-2-3 021860-2-5 021110-1-20 020609-1-15 018936-1-1 023592-1-1 022404-2-4 021860-2-3 021110-1-21 020609-1-16 018936-2-1 023592-1-5 022404-2-5 021860-2-4 021110-1-22 020609-1-19 018936-3-1 023592-1-6 022404-2-6 021860-2-6 021110-1-23 020609-1-20 018936-4-1 023592-1-4 022404-2-7 021860-2-8 021110-1-24 020609-1-17 019179-1-1 023592-1-7 022404-2-8 021860-2-7 021110-1-25 020609-1-21 019254-1-1 023592-1-9 022404-2-9 021860-2-10 021110-1-26 020609-1-18 019323-1-1 023592-1-8 022404-2-10 021860-2-11 021110-1-27 020609-1-23 019383-1-1 023592-1-12 022404-2-11 021860-2-9 021110-1-28 020609-1-22 019409-1-1 023592-1-11 022404-2-12 021860-2-12 021110-1-29 020609-1-24 019410-1-1 023592-1-10 022404-2-13 021860-2-13 021110-1-30 020609-1-26 019549-1-1 023592-1-15 022980-1-3 021860-2-14 021110-1-33 020609-1-27 019613-1-1 023592-1-16 022980-1-1 021860-2-15 021110-1-31 020609-1-25 019671-1-1 023592-1-17 022980-1-2 021860-2-16 021110-1-34 020609-1-28 019747-1-1 023592-1-18 022980-1-4 021860-2-17 021110-1-35 020609-1-30 019782-1-1 023592-1-19 022980-1-5 021860-2-18 021110-1-32 020609-1-31 019810-1-1 023592-1-20 022980-1-6 022404-1-2 021110-1-36 020609-1-29 019920-1-1 9755313 022980-1-7 022404-1-1 021110-1-37 020609-1-34 019974-1-1 9755312 022980-1-8 022404-1-3 021110-1-38 020609-1-32 020000-1-1 9757103 022980-1-10 022404-1-4 021110-1-39 020609-1-33 020022-1-1 9757119 022980-1-11 022404-1-5 021110-1-40 020609-1-35 020022-2-1 9755311 022980-1-9 022404-1-6 021860-1-3 020609-1-36 020074-1-1 9759068 022980-1-12 022404-1-7 021860-1-4 020609-1-37 020126-1-1 9757614 022980-1-13 022404-1-8 021860-1-2 020609-1-38 020127-1-1 9761695 022980-1-15 022404-1-9 021860-1-1 020609-1-39 020159-1-1 9760404 022980-1-14 022404-1-10 021860-1-5 020609-1-40 020160-1-1 9762385 022980-1-16 022404-1-11 021860-1-7 021110-1-1 020227-1-1 9759947 022980-1-17 022404-1-12 021860-1-6 021110-1-2 020323-1-1 9759328 022980-1-18 022404-1-13 021860-1-11 021110-1-3 020346-1-1 9762393 022980-1-19 022404-1-14 021860-1-8 021110-1-4 020386-1-1 9763712 022980-1-20 022404-1-15 021860-1-9 021110-1-5 020435-1-1 9763703 022980-1-21 022404-1-16 021860-1-12 021110-1-6 020466-1-1 020609-1-1 020561-1-1 020551-1-1 020505-1-1 /
Other Recalls from Smiths Medical ASD, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1667-2025 | Class I | CADD-Solis HPCA Ambulatory Infusion Pump; Mode... | Apr 10, 2025 |
| Z-1681-2025 | Class I | CADD-Solis Infusion Pump Models: 1) PUMP KIT,... | Apr 10, 2025 |
| Z-1668-2025 | Class I | CADD-Solis VIP Ambulatory Infusion Pump; Mode... | Apr 10, 2025 |
| Z-1662-2025 | Class I | CADD Solis HSPCA Pump | Apr 10, 2025 |
| Z-1682-2025 | Class I | CADD Solis VIP Ambulatory Infusion Pump Models:... | Apr 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.