Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published October 19, 2023

Integra Cranial Access Kit Recall: Packaging Defect May Split Without Compromising

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.

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

🇺🇸 FDA recall #Z-0493-2024Medical deviceIntegra ›
Take action

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 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. Read more at govinfonow.com/recall/57028-integra-cranial-access-kit-recall-packaging-defect-may-split-without.

Source Summary by GovInfoNow · govinfonow.com/recall/57028-integra-cranial-access-kit-recall-packaging-defect-may-split-without · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0493-2024

Cite this page

“Integra Cranial Access Kit Recall: Packaging Defect May Split Without Compromising.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57028-integra-cranial-access-kit-recall-packaging-defect-may-split-without. Based on FDA recall #Z-0493-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0493-2024%22&limit=1).

Integra LifeSciences Corp. recalled Integra Cranial Access Kits on Oct. 19, 2023, according to the FDA. The hazard is a defect in outer packaging that can compromise sterility. Owners should contact the company for remedies.

How to tell if you have it

  • Brand: Integra
  • Product: Integra Cranial Access Kit
  • Catalog Number: INS7040
  • UDI-DI: 10381780431909
  • Lot Number: 6837706
  • Expiration Date: 1-Mar-25
  • Units affected: 59

The hazard

The recall involves a defect in the outer packaging of the Cranial Access Kits. This defect can cause the packaging to split without any additional forces outside, compromising the sterility of the device.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since 2017-08-18. Recent brand recalls include the 2025-02-06 AURORA Surgiscope System Recall and the 2025-01-10 MediHoney Wound Dressing Gel Recall. Other recent recalls of similar products include the 2025-12-15 Intuitive Surgical da Vinci SP Access Port Kit Recall and the 2026-06-12 Medline Convenience Kits Recalls.

How to tell if you have this one

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.

  • Brand
    Integra
  • Category
    Medical device
FDA recall event · 9 products

All 9 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 Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-0491-2024Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND; UDI-DI:10381780263906 Lot Number/Exp. Date : 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-251639 units
Z-0492-2024Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270; UDI-DI: 10381780431930 Lot Number/Exp. Date: 6824670 1-Aug-24 7127164 1-Sep-24173 units
Z-0493-2024Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040; UDI-DI: 10381780431909 Lot Number/Exp. Date: 6837706 1-Mar-2559 units
Z-0494-2024Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280; UDI-DI:10381780431947 Lot Number/Exp. Date: 6788735 1-Mar-25 7078240 1-May-25180 units
Z-0495-2024Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260; UDI-DI: 10381780431923 Lot Number/Exp. Date: 6561324 1-Aug-24 6844177 1-Mar-25 7078242 1-May-25510 units
Z-0496-2024Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250; UDI-DI: 10381780431916 Lot Number/Exp. Date: 6500469 1-Mar-25 6844175 1-Mar-25 7078238 1-May-25485 units
Z-0497-2024Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06; UDI-DI: 10381780263876 Lot Number/Exp. Date: 6844180 1-Dec-23; 7028238 1-Jan-24; 7078247 17-Mar-24 7248995 1-Jun-24160 units
Z-0498-2024Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04; UDI-DI: 10381780263869 Lot Number/Exp. Date: 6788615 1-Dec-23; 7002983 1-Jan-24173 units
Z-0499-2024Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004; UDI-DI: 10381780178095 Lot Number/Exp. Date: 6926457 31-May-241 unit
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging

    Look for catalog number INS7040 and lot number 6837706 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 Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.” 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 55 days after the firm started it.

1. Firm started the recall: Oct 19, 202312. FDA classified it Class II: Dec 6, 202323. Published in FDA’s Enforcement Report: Dec 13, 202332023
  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.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

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-0493-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0493-2024 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