← FDA ENFORCEMENT
Z-2173-2026Class II

Integra LifeSciences Corp. (NeuroSciences)

Recalling firm
Integra LifeSciences Corp. (NeuroSciences)
Product type
Device
Status
Ongoing
Report date
2026-05-20
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 state
NJ
Product quantity
40 packs (200 units)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product 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.

Code / lot info

Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.