FDADecember 22, 2021device
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
covidien lpcovidiencovidien lp
UPCs
00851334007001
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACovidien Mon-a-Therm General Purpose Temperature Probe REF: 900442026-04-23
- FDACovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 900502026-04-23
- FDACovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 900422026-04-23
- FDACovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;2026-04-15
- FDACOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, L...2026-04-15
- FDAHealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product N...2026-01-30
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;2025-09-25
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;2025-09-25
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