Z-1405-2025Class II

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

Name: Z-1405-2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Creator: Smiths Medical ASD, Inc.
Published: 2025-02-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-02-14 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 on 2025-02-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1405-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-14
Posted: 2025-03-20
Recalling firm: Abbott Medical
Product: CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 14, 2025, customers were notified via Urgent Medical Device Correction letters. Consignees were instructed to locate and quarantine all affected product within their institution and destroy them. The recalling firm will contact customers who have returned completed response forms identifying affected products within their possession to discuss credit.
Quantity in commerce: 175,994 US; 45,223 OUS
Distribution: US Nationwide distribution. International distribution pending.
Product codes and lots: 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 /

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1405-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1404-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-20
Z-1405-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-20

Product code CCK

K941982Class IICapnocheckBci, Inc. / cleared 1994-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)