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SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Recalled April 24, 2024 · FDA recall Z-1521-2024 · SonarMed
Hazard
The failure to detect the partial obstruction in a 2.5mm sensor. · FDA Class I
Units
500 units
Sold at
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Description
The failure to detect the partial obstruction in a 2.5mm sensor.
Product
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Manufacturer(s)
SonarMed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →