Integra Cranial Access Kit recall due to outer packaging defect
Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical surgical device where the defect—outer packaging splitting and compromising sterility—directly threatens patient safety. No illnesses or injuries have been reported, and the hazard is potential rather than realized, making this a risk-of-harm product meeting the High severity threshold.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Catalog Number INS7270) due to a defect in the outer packaging. The packaging can split without significant external force, potentially compromising the sterility of the device before use in surgery.
The Integra Cranial Access Kit is a surgical instrument used for access to the subarachnoid space or lateral ventricles of the brain during neurosurgical procedures. Compromised sterility is a critical concern for any surgical device intended for use within the central nervous system.
A total of 173 units have been distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom. The affected lots are: Lot 6824670 (expiration 1-Aug-24) and Lot 7127164 (expiration 1-Sep-24).
Healthcare facilities should immediately discontinue use of affected units and contact Integra LifeSciences Corp. for instructions regarding replacement or return of the recalled kits.
The recalled product
- Product
- Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03