FDA Device recall Z-1520-2024
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring
- FDA Device
- Class I
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class I recall of AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring by Sonarmed, citing the failure to detect the partial obstruction in a 2.5mm sensor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1520-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-21 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sonarmed |
| Distribution | AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA |
Product
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason
The failure to detect the partial obstruction in a 2.5mm sensor.
Identifiers
| code_info | Product Number/CFN: AW-2030; UDI-DI: 10851334007190; Serial Numbers: A20221012, A20221017, A20221024, A20221103, A20221…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1520-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.