Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Recalled by Masimo Corporation Due to Firm has identified a small number of Oximetry...
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 Masimo Corporation directly.
Affected Products
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
Quantity: 21,754 units (21,222) in the U.S. and Puerto Rico)
Why Was This Recalled?
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Masimo Corporation
Masimo Corporation has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report