FDAMarch 21, 2024device
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The failure to detect the partial obstruction in a 2.5mm sensor.
What to do
FDA enforcement status: Ongoing
Brands named
sonarmed
UPCs
10851334007190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.2024-03-25
- FDAAW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.2024-03-21
- FDAAW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.2024-03-21
- FDASonarMed AirWave Monitor, Model Number M00012017-04-17
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