Class I

Medical Device Recall: AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

SonarMed Inc · March 21, 2024

Reason for Recall

The failure to detect the partial obstruction in a 2.5mm sensor.

Distribution

Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.

States Affected

AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA

Quantity Affected

690 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1520-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.