Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Cathe
FDA device recall Z-2173-2026 · posted 2026-05-13 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Reason for recall
- Out-of-specification endotoxin result that did not meet the acceptance criteria.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JXG
- Quantity affected
- 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), N
- Date initiated
- 2026-04-10
- Date posted
- 2026-05-13
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SureFlo EVD Catheter (K170599) | Arkis Biosciences, Inc. | 2017-08-31 |