Integra LifeSciences recalls Codman CerebroFlo EVD catheters with endotoxin results outside safety limits. Affected units have Product ID 37.550.501. Contact for remedy details.
“Codman CerebroFlo EVD Catheter Recall: Endotoxin Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49520-codman-cerebroflo-evd-catheter-recall-endotoxin-risk. Based on FDA recall #Z-2173-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2026%22&limit=1).
The FDA announced on April 10, 2026, that Integra LifeSciences Corp. (NeuroSciences) is recalling Codman CerebroFlo EVD Catheters with Endexo Technology due to out-of-specification endotoxin results. The agency issued recall number Z-2173-2026 for the Class II device.
How to tell if you have it
Brand: Integra LifeSciences
Product: Codman CerebroFlo EVD Catheter with Endexo Technology
Product ID: 37.550.501
Lot Number: 45322
Quantity: 40 packs (200 units)
The hazard
The recall addresses out-of-specification endotoxin results that did not meet acceptance criteria for the Codman CerebroFlo EVD Catheter. The device is a 3.3 mm diameter, 35 cm long polyurethane catheter designed to divert cerebrospinal fluid from the brain's ventricles.
Context
GovInfoNow's records show Integra LifeSciences Corp. (NeuroSciences) has had 12 other recalls on record since April 4, 2025. Other recent recalls of similar products include the Integra Cytal Wound Matrix 2-Layer recall dated March 19, 2026, and the Medtronic Neurosurgery Ventriculostomy Kit recall dated June 17, 2026.
How to tell if you have this one
Check for Product ID 37.550.501 on the catheter packaging. The catheter is a 3.3 mm diameter, 35 cm long polyurethane tube used for draining brain fluid.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product ID
Look for Product ID 37.550.501 on the catheter packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND),…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Connecticut, Florida, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Oregon, Texas, Washington.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2173-2026 (April 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2173-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.