CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

Codman CerebroFlo EVD Catheter with Endexo Technology recalled

Integra LifeSciences Corp. (NeuroSciences) is recalling Codman CerebroFlo EVD Catheter with Endexo Technology, distributed nationwide in the US. The recall was initiated on 10 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

Quantity recalled40 packs (200 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2173-2026
FDA event ID: 98752
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 10 Apr 2026
FDA classified: 13 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 Apr 2026	Recall initiated by company
13 May 2026	Classified by FDA	+33 days
20 May 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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).

Nationwide Arkansas Arizona California Connecticut Florida Kentucky Louisiana Michigan Minnesota Missouri North Carolina North Dakota Oklahoma Oregon Texas Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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