Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra Cranial Access Kit Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management Due to Integra LifeSciences is voluntarily recalling any unexpired lots...
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. d.b.a. Integra Pain Management directly.
Affected Products
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.
Quantity: 731
Why Was This Recalled?
Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra LifeSciences Corp. d.b.a. Integra Pain Management has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report