SonarMed Inc: Medical Device Recall in 2024 - (Recall #: Z-1521-2024)

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-S035 NEO SONARMED SENSOR 3.5MM. 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-1521-2024

Event ID: 94292

Reason for Recall:

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

Status: Ongoing

Product Quantity: 500 units

Code Information:

Product Number/CFN: AW-S035; UDI-DI: 10851334007206; Serial Numbers: A20221012, A20221019, A20221026, A20221109, A20221110, A20221111, A20221114, A20221212, A20221213, A20221214, A20221215, A20221216, A20230110, A20230111, A20230112, A20230113, A20230116, A20230130, A20230131, A20230202, A20230206, A20230306, A20230307.

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