SonarMed AirWave Monitor Kit — Class II medical device recall Z-0514-2022
Ongoing recall by Covidien, LP, reported 2022-01-26, distributed in CA, CO, FL, IL, KY, MA, OH, TN…. Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely de
| Recall number | Z-0514-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2021-12-22 |
| Classified | 2022-01-19 |
| Reported by FDA | 2022-01-26 |
| Distributed | CA, CO, FL, IL, KY, MA, OH, TN, TX |
| Quantity | 66 devices |
| UPC / GTIN / UDI-DI | 00851334007001 |
| Serial numbers | AW0501, AW0502, AW0503, AW0504, AW0505, AW0506, AW0507, AW0508, AW0509, AW0510, AW0511, AW0512, AW0513, AW0514, AW0515, AW0516, AW0517, AW0519, AW0520, AW0521, AW0522, AW0524, AW0525, AW0526, AW0527 and 41 more |
| Model numbers | AW-M0001 |
Product
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0514-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.