Recall archive / FDA device enforcement
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring. — FDA record Z-1520-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- SonarMed Inc
- Quantity
- 690 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1520-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 24, 2024
- Recall initiation date
- Mar 21, 2024
- Center classification date
- Apr 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.