SonarMed Inc. is recalling approximately 1,800 NEO SonarMed Sensors (models 2.5mm, 3.0mm, and 3.5mm) used in neonatal airway monitoring. These sensors may fail to detect partial obstructions in the breathing tubes of critically ill infants, which can lead to insufficient ventilation. Affected units were distributed domestically across 19 states and are used in conjunction with the SonarMed Monitor to ensure proper breathing tube placement and function. Consumers should identify these sensors by their specific serial numbers and contact their healthcare provider or the manufacturer for further instructions.
The 2.5mm sensor may fail to alert medical staff when a breathing tube is partially blocked. This failure to detect a restricted airway can result in inadequate oxygen delivery or carbon dioxide buildup in vulnerable neonatal patients, potentially causing serious respiratory distress or injury.
Manufacturer Notification and Correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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