Recall Z-1036-2026— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1036-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-12-12. It names one FDA 510(k) clearance: K153347. Product: Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.. Reason: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class II
Status: Ongoing
Initiated: 2025-12-12
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K153347 — Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc.·cleared 2016-08-19

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 Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Reason for recall

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

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