FDA Device recall Z-1521-2024
AW-S035 NEO SONARMED SENSOR 3.5MM. 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-S035 NEO SONARMED SENSOR 3.5MM. 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-1521-2024 |
| 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-S035 NEO SONARMED SENSOR 3.5MM. 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-S035; UDI-DI: 10851334007206; Serial Numbers: A20221012, A20221019, A20221026, A20221109, A20221…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. |
|---|
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-1521-2024%22
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