CereLink pressure sensor kits recalled over corrosion stains on the needle
Integra LifeSciences is recalling 5,116 Codman CereLink ICP Sensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites potential corrosion stains on a component with no stated consequence or reported harm.
Plain-English summary
The Codman CereLink ICP Sensor Basic Kit, catalog number 826850, is being recalled by Integra LifeSciences Corp. The record describes the kit as consisting of the CereLink ICP Sensor, a nylon tube with a microminiature sensor, and a 14-gauge Tuohy needle with stylet.
The reason given in the enforcement record is potential corrosion stains on the surface of the 14-gauge Tuohy needle that is included in the Microsensor and Cerelink ICP kits.
The record lists 5,116 units carrying UDI-DI 10381780520672, across lots including 7261958, 7266691, 7266692, 7288060 and 7293837. Distribution was worldwide, including nationwide across the United States. The FDA has classified the action as Class II.
The record describes surface staining on a kit component and states no consequence or reported injuries. Facilities should quarantine affected lots and follow Integra's instructions.
The recalled product
- 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 transduc
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- corrosion
- needle
- component-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22