FDA-Device2026-05-20Class IIPROCESSING DEFECT
Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
OTHERNationwide distribution
Codman CerebroFlo EVD Catheter recalled for endotoxin contamination
Integra LifeSciences recalled Codman CerebroFlo EVD Catheters (Product ID 37.550.501, Lot 45322) because testing found endotoxin levels that exceeded safety standards. Endotoxins are bacterial fragments that can trigger harmful immune responses in patients. The affected catheters are used to drain fluid from the brain in hospital settings.
- If your facility received this product, do not use it and quarantine the affected lot immediately.
- Contact your hospital's medical device or infection control team and your supplier for return instructions.
- Check your inventory for Lot 45322 and verify product ID 37.550.501.
Hazard
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Sold states
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).
Affected count
40 packs (200 units)
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2173-2026More Integra LifeSciences Corp. (NeuroSciences) recalls
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix 2-Layer recalled for high endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
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