CLASS II ONGOING Device recall · Reported 26 Jan 2022 · FDA Enforcement Report

SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord) recalled

Covidien is recalling SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), distributed in 9 states. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-Device Identifier (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 recalled66 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0514-2022
FDA event ID: 89283
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 22 Dec 2021
FDA classified: 19 Jan 2022
Reported: 26 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

22 Dec 2021	Recall initiated by company
19 Jan 2022	Classified by FDA	+28 days
26 Jan 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

Where it was distributed

The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.

California Colorado Florida Illinois Kentucky Massachusetts Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-Device Identifier (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

Where was it sold?

The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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