Cranial Access Kit recalled due to sterile packaging integrity defect
Integra LifeSciences is recalling a Cranial Access Kit due to packaging defects that may compromise sterility. The product was distributed worldwide.
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 recall for a potential sterility compromise of a neurosurgical device used in brain surgery. Although no illnesses or injuries have been reported and the sterility compromise is theoretical, the risk-of-harm to patients is significant given the critical nature of the affected device.
Plain-English summary
Integra LifeSciences Corp. has issued a nationwide and international recall of Cranial Access Kit, Ref No: 31156 (containing components INS-8301, INS-4500, and INS-HITH), used for accessing the subarachnoid space or lateral ventricles of the brain. The recall affects 4 units distributed worldwide, including the United States and multiple international locations.
The defect involves the sterile packaging (header bag) used for this neurosurgical device. Testing revealed that the packaging fails to meet required integrity criteria, which means the product sterility may be compromised. Integra LifeSciences identified this defect and initiated the recall.
Patients who have received this device or facilities that have this product in stock should contact Integra LifeSciences Corp. to determine if they have affected units. The recalled lot number is 7281021, with an expiration date of April 1, 2024.
The recalled product
- Product
- Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 4
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: 10381780178255 Lot Number: 7281021 Exp. Date: 1-Apr-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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 11 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCranial Access Kit Recall Due to Packaging Defect Compromising Sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit packaging defect compromises device sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit recalled due to packaging defect
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit recall due to outer packaging defect
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility
FDA (Devices) · 2023-12-13
- HighIntegra Cranial Access Kit Packaging Defect Compromises Sterility
FDA (Devices) · 2023-12-13