Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between Recalled by Natus Medical Incorporated Due to The second generation neoBLUE 2 lights with a...
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
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
Quantity: 4,371 units (3,285 units in the US and 1,086 units outside of the US)
Why Was This Recalled?
The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
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.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report