SonarMed Inc Recalls

4 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (4)

March 25, 2024
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Class I
March 21, 2024
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Class I
March 21, 2024
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Class I
March 21, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Class I

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