FDA Device recall Z-2173-2026
Codman CerebroFlo EVD Catheter with Endexo Technology
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Codman CerebroFlo EVD Catheter with Endexo Technology by Integra Lifesciences Neurosciences, citing out-of-specification endotoxin result that did not meet the acceptance criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2173-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-10 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
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.
Reason
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Identifiers
| code_info | Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2026%22
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