Key facts
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| 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. |
| Classification | Class II |
| Recall number | Z-2173-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Out-of-specification endotoxin result that did not meet the acceptance criteria. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Integra LifeSciences Corp. (NeuroSciences) and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Out-of-specification endotoxin result that did not meet the acceptance criteria.. The recall is tracked under FDA recall number Z-2173-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with 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 (additional items listed in FDA's full record) -- and the recall number Z-2173-2026. If it matches, stop using or distributing it and contact Integra LifeSciences Corp. (NeuroSciences) or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
Integra LifeSciences Corp. (NeuroSciences)’s FDA history
Argus HQ has recorded 7 total FDA actions tied to Integra LifeSciences Corp. (NeuroSciences): 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's 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 (additional items listed.
- Has Integra LifeSciences Corp. (NeuroSciences) had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 7 total FDA actions tied to Integra LifeSciences Corp. (NeuroSciences), including 7 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2173-2026.
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Related enforcement actions
Full FDA history for Integra LifeSciences Corp. (NeuroSciences)Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains… by Integra LifeSciences Corp. (NeuroSciences) — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-integra-lifesciences-corp-neurosciences-z-2173-2026
"FDA Class II Recall: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains… by Integra LifeSciences Corp. (NeuroSciences) — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-integra-lifesciences-corp-neurosciences-z-2173-2026.
Argus HQ Research. "FDA Class II Recall: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains… by Integra LifeSciences Corp. (NeuroSciences) — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-integra-lifesciences-corp-neurosciences-z-2173-2026.
@misc{argushq_argushq_ai_recall_fda_recall_integra_lifesciences_corp_neurosciences_z_2173_2026_2026,
title = {FDA Class II Recall: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains… by Integra LifeSciences Corp. (NeuroSciences) — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-integra-lifesciences-corp-neurosciences-z-2173-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗

