Integra LifeSciences Corp. (NeuroSciences) recalls Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.…

Out-of-specification endotoxin result that did not meet the acceptance criteria.

Integra notified consignees on about 04/10/2026 via letter. Consignees at medical facilities were instructed to examine inventory for affected units, remove them immediately from service and quarantine them, forward the notification to those who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas, and complete and return the "Medical Facility Acknowledgement Form provided. Integra Customer Care will contact consignees who have noted affected product on hand and provide a Return Material Authorization (RMA) number and directions to return the affected product. Distributors were instructed to remove the product from further distribution, complete and return the Acknowledgement Form, check customer traceability records and notify them if they have any shipments of affected product, modify the acknowledgement form to provide to their customers, collect completed response forms and affected product from customers and report to Integra on distributor reply form. When the form is received, and it is noted that affected product is on hand, Integra Customer Care will contact distributors and provide a Return Material Authorization (RMA) number and directions to return the affected product.

• FDA enforcement recordOfficial FDA database entry for Z-2173-2026
• FDA 510(k) clearance · K170599The device's official FDA premarket clearance record
• FDA device classification · JXGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.5550The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.