AW-M0001 SONARMED MONITOR — Class I medical device recall Z-1535-2024
Ongoing recall by SonarMed Inc, reported 2024-04-24, distributed in AZ, CA, FL, IL, KY, MD, MO, NC…. Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to
| Recall number | Z-1535-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SonarMed Inc, Carmel, IN, United States |
| Recall initiated | 2024-03-25 |
| Classified | 2024-04-18 |
| Reported by FDA | 2024-04-24 |
| Distributed | AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA |
| Quantity | 145 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00851334007001 |
| Serial numbers | AW0572, AW0573, AW0574, AW0577, AW0578, AW0579, AW0580, AW0581, AW0584, AW0585, AW0586, AW0588, AW0591, AW0593, AW0594, AW0600, AW0606, AW0607, AW0615, AW0616, AW0624, AW0626, AW0627, AW0648, AW0650 and 120 more |
| Model numbers | AW-M0001 |
Product
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Reason for recall
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the 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-1535-2024. 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.