FDA Medical devices recall ·
Codman CerebroFlo EVD Catheter with Endexo Technology recall
- Recall number
- Z-2173-2026
- Date
- (initiated April 10, 2026)
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 40 packs (200 units)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Out-of-specification endotoxin result that did not meet the acceptance criteria.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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).
States: Arkansas Arizona California Connecticut Florida Kentucky Louisiana Michigan Minnesota Missouri North Carolina North Dakota Oklahoma Oregon Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2173-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.