Integra Cranial Access Kit Packaging Defect Compromises Sterility
Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.
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 an FDA Class II medical device recall where a packaging defect compromises the sterility of devices used in neurosurgery, creating a risk of infection. The defect presents potential for serious harm, meeting the rubric criterion for risk-of-harm products (Score 3).
Plain-English summary
Integra LifeSciences Corp. is recalling 180 units of the Integra® Cranial Access Kit (Catalog Number INS7280) used for access to the subarachnoid space or lateral ventricles of the brain during neurosurgery.
A defect in the outer packaging can cause the packaging to split without additional external force, compromising the sterility of the device. Non-sterile instruments in neurosurgical procedures create a risk of infection and contamination.
The affected units were 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 lot numbers are 6788735 (expiration 1-Mar-25) and 7078240 (expiration 1-May-25).
Healthcare facilities and users who have these kits should immediately discontinue use, quarantine the affected units, and contact Integra LifeSciences Corp. for return and replacement instructions.
The recalled product
- Product
- Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 180
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:10381780431947 Lot Number/Exp. Date: 6788735 1-Mar-25 7078240 1-May-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.
See all 9 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · packaging defect
See all →- High
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- HighIntegra Cranial Access Kit Recall Due to Sterile Packaging Defect
FDA (Devices) · 2024-03-06
- HighIntegra Cranial Access Kit Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-03-06
- HighIntegra Cranial Access Kit recall over sterile packaging defect
FDA (Devices) · 2024-03-06
- HighIntegra Cranial Access Kit Recalled Due to Sterile Packaging Defect
FDA (Devices) · 2024-03-06
- HighIntegra Cranial Access Kit Recalled Due to Packaging Integrity Defect
FDA (Devices) · 2024-03-06
- HighIntegra Cranial Access Kit Recalled for Sterile Packaging Defect
FDA (Devices) · 2024-03-06