SonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure
SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.
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: This is an FDA Class I recall, which establishes a minimum severity of Severe per the rubric. The device can fail to detect airway obstruction, a critical safety function. No illnesses or injuries are reported in the source text.
Plain-English summary
The AW-S025 NEO SONARMED SENSOR 2.5MM is an airway monitoring sensor manufactured by SonarMed Inc, designed to work in conjunction with the SonarMed Monitor for continuous patient airway observation in healthcare settings.
Approximately 610 units were distributed across 20 U.S. states: Alaska, Arizona, California, Florida, Illinois, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington.
The recall addresses a device failure wherein the 2.5mm sensor can fail to detect partial obstruction. When the obstruction detection function fails, clinicians may not receive alerts about compromised patient airways.
The affected serial numbers include batch codes from October 2022 through July 2023 (A20221012 through A20230725). The FDA has classified this as a Class I recall due to the serious potential for patient harm if airway obstruction goes undetected during patient monitoring.
The recalled product
- Product
- AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Manufacturer
- SonarMed Inc
- Affected units
- 610
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-S025
- UDI-DI: 10851334007183
- Serial Numbers: A20221012
- A20221018
- A20221025
- A20221107
- A20221109
- A20221202
- A20221206
- A20221207
- A20221208
- A20221209
- A20230105
- A20230109
- A20230123
- A20230124
- A20230125
- A20230126
- A20230213
- A20230224
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
- SevereFDA Recalls SonarMed Airway Sensor for Obstruction Detection Failure
FDA (Devices) · 2024-04-24
- SevereMedical Device Airway Monitor Software Defect Prevents Obstruction Detection
FDA (Devices) · 2024-04-24
- ModerateSonarMed AirWave Monitor Recalled Due to Potential Error Codes
FDA (Devices) · 2019-09-11
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