SonarMed recalls

2 official recalls and safety alerts involving SonarMed since 2024-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with SonarMed or the relevant agency.

1. 2024-04-24
2. US
   Drugs & medicalClass I

   SonarMed Inc recalls 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.

   FDA · DeviceSonarMed Inc_AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_Official notice →
3. US
   Drugs & medicalClass I

   SonarMed Inc recalls 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.

   FDA · DeviceSonarMed IncDomestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX,…Official notice →