Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep Recalled by Integra LifeSciences Corp. Due to A defect in the sterile packaging (header bag)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected Products
Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Quantity: 915 units
Why Was This Recalled?
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report