FDA Device recall Z-1037-2026
Codman CereLink ICP Sensor Basic Kit
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of Codman CereLink ICP Sensor Basic Kit by Integra Lifesciences Neurosciences, citing potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1037-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-12 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor 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.
Identifiers
| code_info | Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306…Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7325482, 7307675, 7325481, 7325483, 7325484, 7307673, 7307674, 7325485, 7325486, 7336611, 7336612, 7336614, 7336623, 7336613, 7336615, 7336616, 7336618, 7336619, 7336620, 7336621, 7336622, 7306048, 7306049, 7336626, 7336627, 7336629, 7347166, 7336628, 7346295, 7346297, 7346299, 7346301, 7365434, 7365435, 7392019, 7396607, 7396608, 7396609, 7396610, 7392034, 7392067, 7405790, 7405791, 7405792, 7405793, 7406633, 7406634, 7406636, 7406637, 7406639, 7406640, 7406641, 7406642, 7406635, 7406638, 7408813, 7408815, 7408818, 7408814, 7408816, 7468726, 7468727, 7411801, 7411802, 7414641, 7414642, 7468731, 7468732, 7468745, 7468746, 7468741, 7468742, 7468743, 7468744, 7468771, 7468769, 7468770, 7468773, 7468774, 7468775, 7482179, 7482180, 7482181, 7482182, 748 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1037-2026%22
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