Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra Cranial Access Kits Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management Due to Integra LifeSciences has been notified of a medical...
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 Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Quantity: 710
Why Was This Recalled?
Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.
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