SonarMed Inc: Medical Device Recall in 2024 - (Recall #: Z-1520-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 21, 2024

Date Posted: April 24, 2024

Recall Number: Z-1520-2024

Event ID: 94292

Reason for Recall:

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

Status: Ongoing

Product Quantity: 690 units

Code Information:

Product Number/CFN: AW-2030; UDI-DI: 10851334007190; Serial Numbers: A20221012, A20221017, A20221024, A20221103, A20221115, A20221116, A20221117, A20221118, A20221130, A20221206, A20221222, A20221228, A20221229, A20230104, A20230111, A20230116, A20230117, A20230118, A20230208, A20230209, A20230313, A20230314, A20230315, A20230316, A20230317, A20230405.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated