Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have catalog number INS7040 and were sold with lot number 6837706 through March 2025.
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Integra LifeSciences is recalling cranial access kits used in brain surgery because the outer packaging might split without affecting the device's sterility. This defect could lead to contamination if the packaging splits during use.
The outer packaging of the cranial access kits may split without any external force compromising the sterility of the device. This could potentially lead to contamination if the packaging splits during use, though the defect does not affect the device's functionality.
Healthcare professionals who use these kits for brain surgery procedures are most at risk. The recall applies to kits with catalog number INS7040 that were sold with lot number 6837706 through March 2025.
Check for catalog number INS7040 on the packaging. The affected kits were sold with lot number 6837706 and were manufactured to expire on March 2025.
Look for catalog number INS7040 and lot number 6837706 on the packaging.
The outer packaging may split without compromising the sterility of the device, which could lead to contamination during use.
Check the packaging for catalog number INS7040 and lot number 6837706. If you have these, contact Integra LifeSciences for further instructions.
The recall indicates a potential contamination risk but does not mention any risk of serious injury or death.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0493-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0493-2024 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
