Class II Recall

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

Summary

The FDA issued a Class II for CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 by Smiths Medical ASD, Inc.. Reason: 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.

Details

Source

Device Recall

External ID

Z-1405-2025

Action Date

2025-03-26

Status

Ongoing

Product Description

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

Lot/Code Info: 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 /

Quantity Affected: 175,994 US; 45,223 OUS

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

US Nationwide distribution. International distribution pending.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-02-14

Company

Smiths Medical ASD, Inc.

Minneapolis, MN

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Smiths Medical ASD, Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Smiths Medical ASD, Inc. have FDA actions?

Smiths Medical ASD, Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1405-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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