Integra Cranial Access Kit packaging defect compromises device sterility
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
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: Score 3 applies because this is a Class II medical device with a defined risk of harm—loss of sterility on a device used for invasive brain procedures—and no illnesses or injuries have been reported. The hazard presents a real contamination risk but is currently theoretical in patient impact.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Model INS7040), a medical device designed for access to the subarachnoid space or lateral ventricles of the brain. The recall affects 59 units from Lot 6837706 (expiration date March 1, 2025).
The devices are being recalled due to a defect in the outer packaging. The packaging can split without additional external forces, compromising the sterility of the device. Sterility is critical for medical devices used in invasive procedures such as brain access.
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. Healthcare facilities and users should identify any units from the affected lot and discontinue use. Contact Integra LifeSciences Corp. for instructions on device return or replacement.
The recalled product
- Product
- Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Neurosurgery
- Affected units
- 59
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 (1)
- UDI-DI: 10381780431909 Lot Number/Exp. Date: 6837706 1-Mar-25
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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