Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EDS 3 CSF External Drainage System Recalled by Natus Medical Incorporated Due to Sterility assurance cannot be guaranteed for external drainage...
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
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Quantity: 3,336 units
Why Was This Recalled?
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
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