Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nasal Alar SpO2 Sensor Recalled by Xhale Assurance, Inc. Due to These Instructions for Use has missing instructions related...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Xhale Assurance, Inc. directly.
Affected Products
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision
Quantity: 701,272 devices total
Why Was This Recalled?
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Xhale Assurance, Inc.
Xhale Assurance, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report