Stop using now Medical device recall · FDA · Published January 12, 2021

Natus EDS 3 CSF Drainage System Recall: Risk of Endotoxin Contamination

Natus recalls EDS 3 CSF External Drainage Systems due to potential endotoxin contamination in cerebrospinal fluid drainage. Affected units may pose health risks requiring medical evaluation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1143-2021Medical device Natus ›

Stop using this now

The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

Take action

Contact the company

Recalling firmNatus Manufacturing LimitedIda Business Park, Glenbrack Road · Galway, Ireland

✎ GovInfoNow plain-language explainer

Natus is recalling its EDS 3 CSF External Drainage Systems because they failed pyrogen tests, meaning they could contain harmful endotoxins that might affect cerebrospinal fluid. This is serious for patients using the device for spinal fluid drainage. Read more at govinfonow.com/recall/63432-natus-eds-3-csf-drainage-system-recall-risk-of-endotoxin.

Source Summary by GovInfoNow · govinfonow.com/recall/63432-natus-eds-3-csf-drainage-system-recall-risk-of-endotoxin · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1143-2021

Cite this page

“Natus EDS 3 CSF Drainage System Recall: Risk of Endotoxin Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63432-natus-eds-3-csf-drainage-system-recall-risk-of-endotoxin. Based on FDA recall #Z-1143-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2021%22&limit=1).

Natus Manufacturing Limited recalled Ref: NT821731C Natus EDS 3 CSF External Drainage System due to pyrogen test failures, according to the FDA on Jan. 12, 2021.

How to tell if you have it

Brand: Natus
Product: Ref: NT821731C, Natus EDS 3 CSF External Drainage System
Lot #: 118000422298

The hazard

The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

Context

GovInfoNow's records show other recent recalls of similar products include Codman CerebroFlo EVD Catheter Recall: Endotoxin Risk (2026-04-10), Medline Medical Kits Recall: Potential Endotoxin Risk in Neurosponges (2026-07-08), and Medtronic Neurosurgery Ventriculostomy Kit Recall: Endotoxin Risk (2026-06-17).

How to tell if you have this one

Check for the model 'EDS 3 CSF External Drainage System' with lot number 118000422298. The product is used for draining cerebrospinal fluid to reduce pressure in the brain.

Brand
Natus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately discontinue use of the Natus EDS 3 CSF External Drainage System if you have it.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Jan 12, 2021Firm started the recall
Feb 22, 2021FDA classified it Class II
Mar 3, 2021Published in FDA’s Enforcement Report
Nov 8, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Natus recalls

Link to this recall

<a href="https://govinfonow.com/recall/63432-natus-eds-3-csf-drainage-system-recall-risk-of-endotoxin">Natus EDS 3 CSF Drainage System Recall: Risk of Endotoxin Contamination (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1143-2021 (January 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1143-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.