AW-S030 NEO SONARMED SENSOR 3 — Class I medical device recall Z-1520-2024
Ongoing recall by SonarMed Inc, reported 2024-04-24, distributed in AK, AZ, CA, FL, IL, KY, MD, MO…. The failure to detect the partial obstruction in a 2.5mm sensor.
| Recall number | Z-1520-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SonarMed Inc, Carmel, IN, United States |
| Recall initiated | 2024-03-21 |
| Classified | 2024-04-18 |
| Reported by FDA | 2024-04-24 |
| Distributed | AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA |
| Quantity | 690 units |
| UPC / GTIN / 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 and 1 more |
Product
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason for recall
The failure to detect the partial obstruction in a 2.5mm sensor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1520-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.