SonarMed AirWave Monitor Kit recall due to alarm and sensor detection failures
Covidien is recalling 66 SonarMed AirWave Monitor Kits because the alarm may fail to sound and sensors may be incorrectly detected as disconnected, potentially causing the monitor to stop monitoring patients without alerting staff.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard—alarm failure and false sensor disconnection in a critical care monitoring device—presents significant risk of patient harm, but no adverse events have been documented. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
SonarMed AirWave Monitor Kit is a medical device consisting of a monitor, sensor cable, and power cord (item code AW-M0001) manufactured by Covidien, LP. The kit is used with endotracheal tubes in critical care settings. Covidien is recalling 66 units that were distributed across nine U.S. states.
The device has two critical defects: the alarm speaker may fail to sound when the device is powered on, and the device may incorrectly detect the sensor cable as disconnected and reconnected during initial setup. If these defects occur, the monitor may stop monitoring the patient and transition to a calibration screen without producing an audible alarm, leaving medical staff unaware that monitoring has ceased.
The recall affects units distributed to California, Colorado, Florida, Illinois, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. Affected devices carry serial numbers from AW0501 to AW0571 and the UDI (GTIN/UPN) 00851334007001.
Healthcare facilities and medical personnel should immediately discontinue use of affected units and contact Covidien for instructions on remedy or replacement. Verify the device serial number against the recall list before continued use.
The recalled product
- Product
- SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
- Manufacturer
- Covidien, LP
- Hazard
- alarm-failure
- false-sensor-disconnect
- monitoring-discontinuation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-Device Identifier (GTIN/UPN): 00851334007001
Distribution
Distributed in 9 states:
- CA
- CO
- FL
- IL
- KY
- MA
- OH
- TN
- TX
Related recalls
Same category
- HighMedline Convenience Kits Containing Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide
FDA (Devices) · 2026-07-08
- ModerateMedline L&D Continuous Epidural Tray Kits Recalled for Quality Issues
FDA (Devices) · 2026-07-08
- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- ModerateZeiss Intrabeam Spherical Applicator failed manufacturing specifications
FDA (Devices) · 2026-07-08