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Unrated Medical device recall · FDA · Published September 26, 2024

Integra Duraform Dural Graft Implant Recall: High Endotoxin Levels Risk

Integra LifeSciences recalls specific Duraform Dural Graft Implant (Model 80-147: Lot CT007694) due to potential endotoxin levels outside specifications. Affected patients should contact for guidance.

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

🇺🇸 FDA recall #Z-0262-2025Medical deviceIntegra LifeSciences ›
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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 a specific Dura: 3x3 size, Model 80-1477US, Lot CT007694. The recall is due to endotoxin levels that may be outside safe specifications, which could pose a risk during medical procedures. Read more at govinfonow.com/recall/53855-integra-duraform-dural-graft-implant-recall-high-endotoxin-levels-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53855-integra-duraform-dural-graft-implant-recall-high-endotoxin-levels-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0262-2025

Cite this page

“Integra Duraform Dural Graft Implant Recall: High Endotoxin Levels Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53855-integra-duraform-dural-graft-implant-recall-high-endotoxin-levels-risk. Based on FDA recall #Z-0262-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0262-2025%22&limit=1).

Integra LifeSciences Corp. voluntarily recalled Duraform Dural Graft Implant Size 3x3 (Model 80-1477US, Lot CT007694) due to out-of-specification endotoxin levels, the FDA said on Sept. 26, 2024.

How to tell if you have it

  • Brand: Integra LifeSciences
  • Product: Duraform Dural Graft Implant, Size 3x3
  • Model Number: 80-1477US
  • Lot Code: CT007694
  • Part Number: 80-1477US
  • UDI: 10886704079477
  • Quantity: 128 units
  • Distribution: China

The hazard

The recall addresses out-of-specification endotoxin levels in the Duraform Dural Graft Implant, according to the FDA.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Other recent recalls of similar products include Integra Cytal Wound Matrix 2-Layer 7x10 cm (March 19, 2026), Integra Cytal Burn Matrix 7x10 cm (March 19, 2026) and Integra Cytal Wound Matrix 2-Layer 5x5 cm (March 19, 2026).

How to tell if you have this one

Check for the model number 80-1477US and lot number CT007694 on the implant packaging or documentation. This specific batch was produced in a particular facility and used in surgeries.

  • Brand
    Integra LifeSciences
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Integra LifeSciences directly for guidance on next steps regarding the recalled implant.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Sep 26, 202412. FDA classified it Class II: Oct 30, 202423. Published in FDA’s Enforcement Report: Nov 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.

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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-0262-2025 (September 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0262-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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