Recall Z-2173-2026— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-2173-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2026-04-10. It names one FDA 510(k) clearance: K170599. 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.. Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class II
Status: Ongoing
Initiated: 2026-04-10
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K170599 — SureFlo EVD CatheterArkis Biosciences, Inc.·cleared 2017-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.