# FDA recall Z-1535-2024

> **SonarMed Inc** · Class I · device recall initiated 2024-03-25.

## 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.

## Distribution

_AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_

## Key facts

- **Recall number:** Z-1535-2024
- **Recalling firm:** SonarMed Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-25
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carmel, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2024

## Citation

> AI Analytics. FDA recall Z-1535-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1535-2024. Source: US FDA. Licensed CC0.

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