Quick Facts at a Glance
- Recall Date
- April 10, 2026
- Hazard Level
- HIGH
- Brand
- Integra LifeSciences Corp.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Integra LifeSciences Corp.
- Model numbers
- Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 10, 2026
Reported by FDA DEVICE
May 20, 2026
RecallRadar source check
May 27, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Out-of-specification endotoxin result that did not meet the acceptance criteria.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Letter
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Full 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.. Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria.. Classification: Class II. Quantity: 40 packs (200 units). 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).
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Safety Guide
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