Integra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility
Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.
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 medical device recall with a defect that directly compromises sterility of a surgical instrument used in critical neurosurgical procedures. No illnesses or injuries have been reported. The hazard is significant and device-critical, but unconfirmed in actual use, qualifying as a high-risk situation where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 510 units of the Integra Cranial Access Kit (Catalog Number INS7260, UDI-DI: 10381780431923) due to a defect in the outer packaging. The packaging can split without additional force, which compromises the sterility of the device.
The Cranial Access Kit is a medical device designed for access to the subarachnoid space or the lateral ventricles of the brain during neurosurgery. A sterile surgical environment is critical for patient safety; compromised sterility increases the risk of infection at the surgical site.
The recalled kits were distributed worldwide, including throughout the United States, Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom. The affected lot numbers and expiration dates are: 6561324 (1-Aug-24), 6844177 (1-Mar-25), and 7078242 (1-May-25).
Healthcare facilities and surgeons in possession of these kits should immediately cease use and contact Integra LifeSciences Corp. for return authorization and replacement units.
The recalled product
- Product
- Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 510
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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