Drug & Device Safety Atlas
Class II FDA device recall · Z-1405-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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  /

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution. International distribution pending.

Recall record

Recalling firm
Smiths Medical ASD, Inc.
Product type
Devices
Recall number
Z-1405-2025
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Minneapolis, MN
Recall initiated
2025-02-14

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1405-2025 · Source: openFDA enforcement.