Integra Cranial Access Kit Recall: Sterile Packaging Risk
Integra LifeSciences recalls cranial access kits without prep solutions due to potential packaging tears that could compromise sterility during ventriculostomy procedures.
Lower-risk recall
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling cranial access kits used in ventriculostomy procedures because the sterile packaging might tear, risking infection. This affects specific lot numbers and catalog numbers. Read more at govinfonow.com/recall/55358-integra-cranial-access-kit-recall-sterile-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/55358-integra-cranial-access-kit-recall-sterile-packaging-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1873-2024
Cite this page
“Integra Cranial Access Kit Recall: Sterile Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55358-integra-cranial-access-kit-recall-sterile-packaging-risk. Based on FDA recall #Z-1873-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1873-2024%22&limit=1).
Why it’s dangerous
The sterile packaging of the cranial access kit may develop holes or tears, which could allow contamination and lead to infection during surgery. This risk occurs because the packaging is designed to be sterile but may not hold that condition without damage.
Who’s affected
Medical professionals using the cranial access kits during ventriculostomy procedures. Patients undergoing the procedure are at risk if the kit's packaging is compromised.
How to tell if you have this one
Check for the catalog number INS5HND or lot numbers listed: 7257032 (07/16/2025), 7275713 (09/03/2025), 7291974 (09/03/2025), 7312131 (09/03/2025), 7289690 (09/03/2025), 7291975 (09/03/2025), 7312137 (09/03/2025), 7312139 (09/03/2025).
- Brand
Integra- Category
Medical device
What to do — step by step
Check Packaging Integrity
Inspect the sterile header bag for any holes or tears before use.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of CA, BE, CL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1873-2024 (April 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1873-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.