Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Natus neoBLUE Phototherapy system Recalled by Natus Medical Incorporated Due to The firm is adding the warning statement to...
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 Natus Medical Incorporated directly.
Affected Products
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
Quantity: 13541 units total (7840 units in the US and 5701 units outside the US)
Why Was This Recalled?
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Natus Medical Incorporated
Natus Medical Incorporated has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report