Covidien recalls SonarMed AirWave Monitor Kit (AW-M0001) used with endotracheal tubes due to false alarm disconnections causing monitoring to stop without warning.
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.
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.
The monitor may falsely detect a sensor cable disconnect during setup, causing it to stop monitoring and switch to calibration without sounding an alarm. This could lead to missed patient vital signs during critical medical procedures.
Healthcare providers using the SonarMed AirWave Monitor Kit with endotracheal tubes are most at risk. Patients receiving critical care with this monitor could be affected if the false disconnection occurs.
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.
Look for the serial numbers listed in the recall (AW0501 to AW0571) on the monitor kit.
Reach out to Covidien for guidance on next steps if you have the recalled kit.
The monitor may falsely detect a sensor cable disconnect during setup, causing it to stop monitoring and switch to calibration without an audible alarm.
Check for the item code AW-M0001 and serial numbers from AW0501 to AW0571 on the monitor kit, which is used with endotracheal tubes.
Contact Covidien for guidance on next steps if you have the recalled kit.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0514-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0514-2022 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
