The Recall Desk

Manufacturer

SonarMed Inc

5 recalls in our database name SonarMed Inc as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
4
Most recent
2024-04-24

Of the 5 recalls from SonarMed Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (80%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • SevereFDA (Devices)·Z-1520-2024·2024-04-24

    SonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction

    SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.

    Product
    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1521-2024·2024-04-24

    FDA Recalls SonarMed Airway Sensor for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S035 NEO airway monitoring sensor due to failure to detect partial obstructions. The defect may prevent the device from alerting clinicians to airway obstruction.

    Product
    AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1535-2024·2024-04-24

    Medical Device Airway Monitor Software Defect Prevents Obstruction Detection

    A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.

    Product
    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-1519-2024·2024-04-24

    SonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.

    Product
    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2450-2019·2019-09-11

    SonarMed AirWave Monitor Recalled Due to Potential Error Codes

    SonarMed Inc is recalling 16 AirWave Monitor units because two error codes may render the devices inoperable.

    Product
    SonarMed AirWave Monitor, Model Number M0001
    Category
    Medical Device
    Distribution
    2 states