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Lower risk Medical device recall · FDA · Published January 19, 2024

Integra Cranial Access Kit Recall: Sterility Risk from Packaging Defect

Integra LifeSciences recalls cranial access kits (without prep solutions) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers and expiration dates. Consumers should contact Integra for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1196-2024Medical deviceIntegra ›
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Contact the company

Recalling firmIntegra LifeSciences Corp.1100 Campus Rd · Princeton, NJ 08540-6650
✎ GovInfoNow plain-language explainer

Integra LifeSciences is recalling cranial access kits without prep solutions because their sterile packaging may have been compromised. This could lead to infections if the kit is used improperly. The recall affects specific lot numbers and expiration dates. Read more at govinfonow.com/recall/56291-integra-cranial-access-kit-recall-sterility-risk-from-packaging-defect.

Source Summary by GovInfoNow · govinfonow.com/recall/56291-integra-cranial-access-kit-recall-sterility-risk-from-packaging-defect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1196-2024

Cite this page

“Integra Cranial Access Kit Recall: Sterility Risk from Packaging Defect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56291-integra-cranial-access-kit-recall-sterility-risk-from-packaging-defect. Based on FDA recall #Z-1196-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1196-2024%22&limit=1).

Integra LifeSciences Corp. recalled Integra Cranial access kits worldwide on Jan. 19, 2024, due to sterile packaging defects that may compromise sterility, the FDA said.

How to tell if you have it

  • Brand: Integra
  • Product: Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard
  • Lot Numbers: 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, 7300837
  • Expiration Dates: 29-Jun-25, 16-Jul-25, 29-Jul-25
  • Units: 1324

The hazard

A defect in the sterile packaging (header bag) of the Cranial Access Kit failed required packaging integrity testing criteria. Therefore, product sterility may be compromised.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Recent brand recalls include the Feb. 6, 2025 AURORA Surgiscope System Recall for risk of obturator breaking and the Jan. 10, 2025 MediHoney Wound Dressing Gel Recall for induction seal packaging risk. Other recent recalls of similar products include the Jan. 7, 2026 Medline Convenience Kits Recall for sterility risk from calibration issues and the June 12, 2026 Medline Convenience Kits Recall for risk of sterile packaging breach.

How to tell if you have this one

Check the product label for lot numbers: 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, or 7300837. The expiration date is listed as 29-Jun-25 through 16-Jul-25.

  • Brand
    Integra
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).
Recall numberProduct, codes & lotsQuantity
Z-1193-2024Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780178255 Lot Number: 7281021 Exp. Date: 1-Apr-244 units
Z-1194-2024Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780263869 Lot Number: 7257028 Exp. Date: 1-Jun-2427 units
Z-1195-2024Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780263876 Lot Number: 7257029 Exp. Date: 1-Jun-2423 units
Z-1196-2024Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780263906 Lot Number Exp Date: 7249001 29-Jun-25 7253133 29-Jun-25 7253134 29-Jun-25 7253135 16-Jul-25 7253136 16-Jul-25 7275711 29-Jul-25 7300837 29-Jun-251324 units
Z-1197-2024Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI:10381780431916 Lot Number: 7124718 Exp Date: 1-Sep-24188 units
Z-1198-2024Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI:10381780431923 Lot Number: 7124720 Exp Date: 1-Sep-24161 units
Z-1199-2024Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780431930 Lot Number: 7257036 Exp: Date: 1-Sep-2430 units
Z-1200-2024INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780431947 Lot Number: 7127160 Exp: Date: 1-Sep-2482 units
Z-1201-2024Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780263968 Lot Number Exp: Date: 6631603 1-Sep-23 6631604 1-Sep-23 6710212 1-Sep-23 6710213 1-Sep-23 6788598 1-Sep-23 6788599 1-Dec-23 6788600 1-Jan-24 6896383 1-Dec-23 6896384 1-Jan-24 6896385 1-Jan-24 6955153 17-Mar-24 6955154 17-Mar-24 6955155 17-Mar-24 7000260 17-Mar-24 7000261 17-Mar-24 7000262 17-Mar-24 7028225 17-Mar-24 7028226 17-Mar-24 7028227 1-Apr-24 7073035 1-Apr-24 7073036 1-Apr-24 7073037 1-Apr-24 7124699 1-Apr-24 7124700 1-Apr-24 7124702 1-Apr-24 7249008 1-Jun-24 7249009 1-Jun-24 7257038 1-Jun-24 7257039 1-Jun-24 7257040 1-Jun-248906 units
Z-1202-2024Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780263975 Lot Number Exp: Date: 6710227 30-Jun-24 6788602 30-Jun-24 6955170 7-Feb-25 7000268 7-Feb-05 7028247 10-Apr-25 7078234 11-May-25 7249010 18-Jul-25 7253163 22-Jun-25915 units
Z-1203-2024Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.; UDI: 10381780263982 Lot Number Exp: Date: 6631607 1-Sep-23 6631608 1-Dec-23 6710216 1-Sep-23 6710217 1-Dec-23 6788605 1-Jan-24 6788606 1-Jan-24 6896388 17-Mar-24 6896389 1-Dec-23 6955158 17-Mar-24 6955159 17-Mar-24 7000265 17-Mar-24 7000266 17-Mar-24 7028235 17-Mar-24 7073054 17-Mar-24 7073055 1-Apr-24 7124709 1-Apr-24 7124710 1-Apr-24 7249011 1-Apr-24 7253162 1-Jun-24 7257042 1-Jun-24 7257043 1-Jun-24 7264841 1-Jun-246093 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for lot numbers 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, or 7300837 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of…” 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 47 days after the firm started it.

1. Firm started the recall: Jan 19, 202412. FDA classified it Class II: Feb 28, 202423. Published in FDA’s Enforcement Report: Mar 6, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this product?

The recall is due to potential sterility issues, not immediate injury risks. The danger level is low risk.

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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-1196-2024 (January 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1196-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA