Recall archive / FDA device enforcement
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT) — FDA record Z-0514-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 22, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Covidien, LP
- Quantity
- 66 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0514-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 26, 2022
- Recall initiation date
- Dec 22, 2021
- Center classification date
- Jan 19, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.