Z-2173-2026Class II

Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The...

Name: Z-2173-2026 Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2026-04-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2026-04-10 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35... on 2026-04-10. FDA classified it as Class II and gives the reason as "Out-of-specification endotoxin result that did not meet the acceptance criteria". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2173-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-10
Posted: 2026-05-13
Recalling firm: Integra LifeSciences Corporation
Product: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Out-of-specification endotoxin result that did not meet the acceptance criteria.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 40 packs (200 units)
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), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).
Product codes and lots: Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2173-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2173-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-13

Product code JXG

K170599Class IISureFlo EVD CatheterArkis Biosciences, Inc. / cleared 2017-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)