Integra Cranial Access Kit Recalled for Defective Outer Packaging
Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II FDA recall for a surgical device where a packaging defect could compromise sterility. While no illnesses or injuries have been reported, the device is used in neurosurgery where sterility is critical. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Catalog Number: INS5HND), a surgical device used for accessing the subarachnoid space or lateral ventricles of the brain. The recall involves 1,639 units.
The outer packaging of these kits has a defect that can cause it to split without additional external forces. If the packaging splits, the sterility of the device may be compromised.
The affected devices were distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom. Multiple lot numbers are associated with this recall with expiration dates ranging from May 2025 to October 2025.
The recalled product
- Product
- Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Neurosurgical
- Affected units
- 1,639
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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