Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Lot / code information
- UDI
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…Show all
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 /
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution. International distribution pending.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1405-2025
- FDA 510(k) clearance · K941982The device's official FDA premarket clearance record
- FDA device classification · CCKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.1400The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Smiths Medical ASD, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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