Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Recalled by Integra LifeSciences Corp. Due to Potential holes and tears in the sterile packaging...
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
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Quantity: 1,822 units
Why Was This Recalled?
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
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