Codman CereLink ICP Sensor Basic Kit — Class II medical device recall Z-1037-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-01-14, distributed nationwide. Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and
| Recall number | Z-1037-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2025-12-12 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CL, CN, CO, CY, CZ, DE, ES, FR, GB, GR, HK, IE, IL, IN, IS, IT, JP, KE, KR, LT, NP, NZ, PL, PT, RO, SA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 5,116 units |
| UPC / GTIN / UDI-DI | 10381780520672 |
| Lot numbers | 7261958, 7266691, 7266692, 7288060, 7293836, 7293837, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306048, 7306049, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7307673, 7307674, 7307675, 7325481, 7325482, 7325483, 7325484, 7325485, 7325486, 7336611, 7336612, 7336613, 7336614, 7336615, 7336616, 7336618, 7336619, 7336620 and 177 more |
| Model numbers | 826850 |
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 for recall
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1037-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.