SonarMed Inc: Medical Device Recall in 2024 - (Recall #: Z-1519-2024)

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-S025 NEO SONARMED SENSOR 2.5MM. 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-1519-2024

Event ID: 94292

Reason for Recall:

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

Status: Ongoing

Product Quantity: 610 units

Code Information:

Product Number/CFN: AW-S025; UDI-DI: 10851334007183; Serial Numbers: A20221012, A20221018, A20221025, A20221107, A20221109, A20221202, A20221206, A20221207, A20221208, A20221209, A20230105, A20230109, A20230123, A20230124, A20230125, A20230126, A20230213, A20230224, A20230228, A20230301, A20230302, A20230303, A20230320, A20230324, A20230411, A20230724, A20230725.

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