--- title: "AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... — FDA record Z-1535-2024 | Is It on Recall" description: "Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor." url: https://isitonrecall.com/recall/fda-device-z-1535-2024-aw-m0001-sonarmed-monitor-used-in-conjunction-with-sonarmed-acoustic-sensors-for-airway-monitoring/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. — FDA record Z-1535-2024 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 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. - **Reason**: Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. - **Classification**: Class I - **Recalling firm**: SonarMed Inc - **Quantity**: 145 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1535-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1535-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model No. AW-M0001; GTIN: 00851334007001; Serial No. 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, AW0651, AW0658, AW0664, AW0672, AW0674, AW0675, AW0678, AW0680, AW0681, AW0684, AW0685, AW0701, AW0702, AW0703, AW0704, AW0705, AW0706, AW0707, AW0708, AW0709, AW0710, AW0711, AW0712, AW0718, AW0719, AW0720, AW0721, AW0722, AW0723, AW0724, AW0725, AW0726, AW0727, AW0728, AW0729, AW0730, AW0731, AW0732, AW0733, AW0734, AW0735, AW0736, AW0737, AW0738, AW0739, AW0740, AW0741, AW0742, AW0743, AW0744, AW0745, AW0746, AW0747, AW0748, AW0749, AW0763, AW0764, AW0765, AW0766, AW0767, AW0768, AW0769, AW0770, AW0771, AW0772, AW0773, AW0774, AW0775, AW0776, AW0777, AW0778, AW0779, AW0780, AW0781, AW0782, AW0783, AW0784, AW0785, AW0786, AW0787, AW0788, AW0789, AW0790, AW0791, AW0792, AW0793, AW0794, AW0795, AW0796, AW0797, AW0798, AW0799, AW0800, AW0804, AW0805, AW0814, AW0817, AW0818, AW0819, AW0820, AW0821, AW0825, AW0826, AW0827, AW0828, AW0830, AW0831, AW0832, AW0833, AW0834, AW0835, AW0836, AW0837, AW0838, AW0839, AW0840, AW0841, AW0842, AW0854, AW0855. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution \_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. - [Alaska](https://isitonrecall.com/state/alaska/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Florida](https://isitonrecall.com/state/florida/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Missouri](https://isitonrecall.com/state/missouri/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Washington](https://isitonrecall.com/state/washington/) ## Dates in the source - **Report date**: Apr 24, 2024 - **Recall initiation date**: Mar 25, 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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1535-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [SonarMed Inc records](https://isitonrecall.com/brand/sonarmed-inc/)