FDAClass II · Medical device · Recalled May 20, 2026

Codman CerebroFlo EVD Catheter with Endexo Technology recall — Integra LifeSciences Corp. (NeuroSciences)

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2173-2026
Brand: Integra LifeSciences (NeuroSciences)
Classification: Class II
Units affected: 40 packs (200 units)
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Codman CerebroFlo EVD Catheter with Endexo Technology

Companies & origin

Recalling firm location: Princeton, NJ, United States
Firm address: 1100 Campus Rd, 08540-6650

Identifying details (verbatim from the notice)

Product codes / lots: Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
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).
Firm notified the public via: Letter
FDA event ID: 98752
Recall initiated: April 10, 2026
FDA classified: May 13, 2026
FDA report date: May 20, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 1:09 AM UTC.

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