Codman CerebroFlo EVD Catheter with Endexo Technology — Class II medical device recall Z-2173-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-05-20, distributed nationwide. Out-of-specification endotoxin result that did not meet the acceptance criteria.
| Recall number | Z-2173-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2026-04-10 |
| Classified | 2026-05-13 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780530138 |
| Lot numbers | 45322 |
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 for recall
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2173-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.