FDA Recalls SonarMed Airway Sensor for Obstruction Detection Failure
SonarMed Inc is recalling the AW-S035 NEO airway monitoring sensor due to failure to detect partial obstructions. The defect may prevent the device from alerting clinicians to airway obstruction.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The failure to detect airway obstruction in a monitoring device creates serious patient safety risk. No illnesses or deaths are reported in the source.
Plain-English summary
SonarMed Inc is recalling 500 units of the AW-S035 NEO SONARMED SENSOR 3.5MM, an airway monitoring sensor used with the SonarMed Monitor.
The FDA issued a Class I recall because the sensor may fail to detect partial airway obstruction, preventing the device from alerting clinicians to the presence of airway obstruction.
The recalled sensors were distributed to healthcare facilities in Alaska, Arizona, California, Florida, Illinois, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington. Affected units have specific serial numbers from production batches dated in 2022 and 2023.
Healthcare facilities should verify any AW-S035 sensors against the affected serial numbers and contact SonarMed Inc for replacement or further instructions. Units matching the recalled serial numbers should not be used.
The recalled product
- Product
- AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Manufacturer
- SonarMed Inc
- Affected units
- 500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Number/CFN: AW-S035
- UDI-DI: 10851334007206
- Serial Numbers: A20221012
- A20221019
- A20221026
- A20221109
- A20221110
- A20221111
- A20221114
- A20221212
- A20221213
- A20221214
- A20221215
- A20221216
- A20230110
- A20230111
- A20230112
- A20230113
- A20230116
- A20230130
Distribution
Part of a larger recall action
This product is one of 3 recalled by SonarMed Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · SonarMed Inc
See all →- SevereSonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction
FDA (Devices) · 2024-04-24
- SevereMedical Device Airway Monitor Software Defect Prevents Obstruction Detection
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- SevereSonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure
FDA (Devices) · 2024-04-24
- ModerateSonarMed AirWave Monitor Recalled Due to Potential Error Codes
FDA (Devices) · 2019-09-11
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