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Unrated Medical device recall · FDA · Published June 13, 2023

Medtronic Durepair Dura Regeneration Matrix: Risk of infection from endotoxin levels

Medtronic recalls Durepair Dura Regeneration Matrix products with potential endotoxin levels that may cause infection-like symptoms. Affected items include specific sizes and expiration dates listed in the recall notice.

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

🇺🇸 FDA recall #Z-2207-2023Medical deviceMedtronic Neurosurgery ›
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Contact the company

Recalling firmMedtronic Neurosurgery5290 California Ave · Irvine, CA 92617-3073
✎ GovInfoNow plain-language explainer

Medtronic is recalling certain Durepair Dura Regeneration Matrix products due to possible endotoxin levels that could cause infection-like symptoms. These products are used in neurosurgery and were manufactured with specific model numbers and expiration dates. Read more at govinfonow.com/recall/57855-medtronic-durepair-dura-regeneration-matrix-risk-of-infection-from-endotoxin.

Source Summary by GovInfoNow · govinfonow.com/recall/57855-medtronic-durepair-dura-regeneration-matrix-risk-of-infection-from-endotoxin · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2207-2023

Cite this page

“Medtronic Durepair Dura Regeneration Matrix: Risk of infection from endotoxin levels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57855-medtronic-durepair-dura-regeneration-matrix-risk-of-infection-from-endotoxin. Based on FDA recall #Z-2207-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2023%22&limit=1).

The FDA announced on June 13, 2023, that Medtronic Neurosurgery is recalling Durepair Dura Regeneration Matrix products due to potential out-of-specification endotoxin levels. The agency said the issue may present clinically with signs and symptoms of an acute inflammatory process comparable to infection.

How to tell if you have it

  • DUREPAIR DURA SUBSTITUTE 2 X 2, 61100
  • DUREPAIR DURA SUBSTITUTE 3 X 3, 61105
  • DUREPAIR DURA SUBSTITUTE 1 X 3, 61106
  • DUREPAIR DURA SUBSTITUTE 4 X 5, 61110
  • DUREPAIR DURA SUBSTITUTE 1 X 1, 61111
  • DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100
  • DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105
  • DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106
  • DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110
  • DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111
  • DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158

The hazard

The FDA said the dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing. The agency stated this may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

Context

GovInfoNow's records show Medtronic Neurosurgery has 9 other recalls on record since December 20, 2017. Other recent recalls of similar products include Integra Cytal Wound Matrix 2-Layer 7x10 cm (March 19, 2026), Medline Medical Procedure Kits with Neuro Sponges (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 model numbers like DUREPAIR DURA SUBSTITUTE 2 X 2 (61100) or 3 X 3 (61105) with expiration dates listed in the recall notice. The products were sold with specific lot numbers and expiration dates from March 2024 to May 2025.

  • Brand
    Medtronic Neurosurgery
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number and expiration date on the product packaging to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution including in the states of PR, TX, WA, HI, MI, GA, AL, IL, IN, IA, MO, KY, NY, CA, AZ, PA, UT, ME, MD, MN, FL, AK, NE, VA, OR, WI, NC, LA, SD, TN, MS, DE, NJ, ID, SC, OH, MA, DC, NM, WV, NH, CT, NV,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Jun 13, 202312. FDA classified it Class II: Jul 20, 202323. Published in FDA’s Enforcement Report: Jul 26, 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.

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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-2207-2023 (June 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2207-2023 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