Use caution Medical device recall · FDA · Published December 22, 2021

Covidien SonarMed AirWave Monitor Kit Recall: False Alarm Discontinues Monitoring

Covidien recalls SonarMed AirWave Monitor Kit (AW-M0001) used with endotracheal tubes due to false alarm disconnections causing monitoring to stop without warning.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0514-2022Medical device Covidien ›

Use caution until it’s fixed

Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.

Take action

Contact the company

Recalling firmCovidien, LP60 Middletown Ave · North Haven, CT 06473-3908

✎ GovInfoNow plain-language explainer

Covidien is recalling SonarMed AirWave Monitor Kits that can falsely detect a sensor cable disconnect, causing the monitor to stop working without an audible alarm. This could lead to missed patient monitoring during critical medical procedures. Read more at govinfonow.com/recall/61374-covidien-sonarmed-airwave-monitor-kit-recall-false-alarm-discontinues-monitoring.

Source Summary by GovInfoNow · govinfonow.com/recall/61374-covidien-sonarmed-airwave-monitor-kit-recall-false-alarm-discontinues-monitoring · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0514-2022

Cite this page

“Covidien SonarMed AirWave Monitor Kit Recall: False Alarm Discontinues Monitoring.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61374-covidien-sonarmed-airwave-monitor-kit-recall-false-alarm-discontinues-monitoring. Based on FDA recall #Z-0514-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0514-2022%22&limit=1).

The FDA announced on Dec. 22, 2021, that Covidien, LP voluntarily recalled the SonarMed AirWave Monitor Kit (Item Code AW-M0001) due to alarm and sensor detection failures. The agency issued recall number Z-0514-2022 for the Class II device.

How to tell if you have it

Brand: Covidien
Product: SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord)
Item Code: AW-M0001
GTIN/UPN: 00851334007001
Serial Numbers: AW0501, AW0519, AW0537, AW0556, AW0502, AW0520, AW0540, AW0557, AW0503, AW0521, AW0541, AW0558, AW0504, AW0522, AW0542, AW0559, AW0505, AW0524, AW0543, AW0560, AW0506, AW0525, AW0544, AW0561, AW0507, AW0526, AW0545, AW0562, AW0508, AW0527, AW0546, AW0563, AW0509, AW0528, AW0548, AW0564, AW0510, AW0529, AW0549, AW0565, AW0511, AW0530, AW0550, AW0566, AW0512, AW0531, AW0551, AW0567, AW0513, AW0532, AW0552, AW0568, AW0514, AW0533, AW0553, AW0569, AW0515, AW0536, AW0554, AW0570, AW0516, AW0538, AW0555, AW0571, AW0517, AW0539
Quantity: 66 devices
Distribution states: CA, CO, FL, IL, KY, MA, OH, TN, TX

The hazard

GovInfoNow's records show the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.

Context

GovInfoNow's records show Covidien, LP has 26 other recalls on record since 2017-07-17. Other recent recalls of similar products include Philips IntelliVue MX800 Patient Monitor Recall: No Alarms May Cause Missed Alerts (2025-10-31), Philips IntelliVue MX450 Patient Monitor Recall: No Alarms May Cause Missed Alerts (2025-10-31) and Philips IntelliVue MX550 Patient Monitor Recall: No Alarms May Cause Missed Alerts (2025-10-31).

How to tell if you have this one

Check for the item code AW-M0001 on the monitor kit. The serial numbers listed in the recall include AW0501 through AW0571. This kit is used with endotracheal tubes in medical settings.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Monitor Serial Number
Look for the serial numbers listed in the recall (AW0501 to AW0571) on the monitor kit.
Contact Manufacturer
Reach out to Covidien for guidance on next steps if you have the recalled kit.

Where it went and when

Where it was distributed

Distributed in 9 states.

FDA distribution: “The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Illinois, Kentucky, Massachusetts, Ohio, Tennessee, Texas.

Recall timeline

FDA published this recall 35 days after the firm started it.

Dec 22, 2021Firm started the recall
Jan 19, 2022FDA classified it Class II
Jan 26, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61374-covidien-sonarmed-airwave-monitor-kit-recall-false-alarm-discontinues-monitoring">Covidien SonarMed AirWave Monitor Kit Recall: False Alarm Discontinues Monitoring (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0514-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0514-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.