SonarMed AirWave Monitor — Class II medical device recall Z-2450-2019
Terminated recall by SonarMed Inc, reported 2019-09-11, distributed in CA, TX. Potential for the presence of two error codes which would make the monitor inoperable.
| Recall number | Z-2450-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SonarMed Inc, Carmel, IN, United States |
| Recall initiated | 2017-04-17 |
| Classified | 2019-09-04 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-07-16 |
| Distributed | CA, TX |
| Quantity | 16 units |
| UPC / GTIN / UDI-DI | 00851334007001 |
| Model numbers | M0001 |
Product
SonarMed AirWave Monitor, Model Number M0001
Reason for recall
Potential for the presence of two error codes which would make the monitor inoperable.
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-2450-2019. 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.