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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Monitoring Devices

CAPNOCHECK Airway Adapters Recalled for Risk of Breakage and Ventilation Loss

Agency Publication Date: March 20, 2025
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Summary

Smiths Medical ASD, Inc. is recalling approximately 175,994 CAPNOCHECK BCI Airway Adapters (Models WW1100 and WW8214) because they may break off when attaching valves or tubes. This defect can lead to inaccurate medical readings, a break in the patient's airway circuit, and a complete loss of mechanical ventilation. These adapters are used in clinical settings and were distributed nationwide across the United States.

Risk

A break in the airway circuit can prevent a patient from receiving necessary oxygen, potentially leading to hypoxia, cardiopulmonary collapse, or death. While no injuries have been reported to date, the device failure poses a severe high-risk threat to patient safety.

What You Should Do

  1. This recall involves CAPNOCHECK BCI Airway Adapters (Model BSR) sold under product codes WW1100 and WW8214.
  2. Identify the affected products by checking the lot number and product code printed on the packaging or device label. Because this recall affects hundreds of unique lot numbers, see the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Smiths Medical ASD, Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected airway adapters.
  5. If you have further questions or need to report a device failure, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CAPNOCHECK BCI Airway Adapter (Model BSR)
Model / REF:
WW1100
Lot Numbers (245):
2367264
4120594
3785503
3372540
3291105
3274449
2373071
4225429
3785504
3372541
3292653
3287858
2658411
4236887
3788853
3381687
3294706
3289019
2690517
4236889
3788854
3386807
3296610
3290566
2695046
4256023
3788855
3406654
3297304
3294707
2792606
4256024
3799595
3411359
3297306
3321359
2823742
4256025
3807283
3437865
3297307
3332595
2843746
4269090
3813374
3444606
3300487
3335022
2898265
4269092
UDI:
35019517062667

Recall #: Z-1404-2025

Product: CAPNOCHECK BCI Airway Adapter (Model BSR)
Model / REF:
WW8214
Lot Numbers (275):
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
UDI:
30610586038444

Recall #: Z-1405-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96238
Status: Active
Manufacturer: Smiths Medical ASD, Inc.
Sold By: Specialty medical equipment distributors; Healthcare facilities; Smiths Medical ASD, Inc.
Manufactured In: United States
Units Affected: 2 products (175,994 US; 45,223 OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.