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Lower risk Medical device recall · FDA · Published December 2, 2022

Integra LifeSciences recalls Codman Surgical Patties with potential minor fever risk

Integra LifeSciences recalls Codman Surgical Patties (part 801400, lot 6396457) due to possible minor fever from endotoxin issues. Affected units may cause temporary fever during surgery.

🇺🇸 FDA recall #Z-0909-2023Medical deviceIntegra LifeSciences ›
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Recalling firmIntegra LifeSciences Corp.1100 Campus Rd · Princeton, NJ 08540-6650
✎ GovInfoNow plain-language explainer

Integra LifeSciences is recalling Codman Surgical Patties with a specific lot number because they may contain endotoxins that could cause a minor fever during surgery. This is a small risk that doesn't require immediate action but should be checked. Read more at govinfonow.com/recall/59258-integra-lifesciences-recalls-codman-surgical-patties-with-potential-minor-fever.

Source Summary by GovInfoNow · govinfonow.com/recall/59258-integra-lifesciences-recalls-codman-surgical-patties-with-potential-minor-fever · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0909-2023

Cite this page

“Integra LifeSciences recalls Codman Surgical Patties with potential minor fever risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59258-integra-lifesciences-recalls-codman-surgical-patties-with-potential-minor-fever. Based on FDA recall #Z-0909-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0909-2023%22&limit=1).

The FDA announced on 2022-12-02 that Integra LifeSciences Corp. is recalling Codman Surgical Patties due to out-of-specification endotoxin results, which could cause minor transient fever. The recall covers Lot 6396457 distributed in the U.S. and several other countries.

How to tell if you have it

  • Brand: Integra LifeSciences
  • Product: Codman Surgical Patties
  • Part number: 801400
  • Product name: SURG PATXRAY 1/2X1/2-200
  • Lot number: 6396457
  • UDI-DI: 10381780514961
  • Expiration date: 06/30/2027

The hazard

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

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 for risk of obturator breaking, the 2025-01-10 MediHoney Wound Dressing Gel Recall for induction seal packaging risk, and the 2024-12-16 CODMAN CERTAS Plus Valve Recall for incorrect labeling risk. Other recent recalls of similar products include the Integra Cytal Burn Matrix 7x10 cm recall (2026-03-19) and the Integra Cytal Wound Matrix 2-Layer 5x5 cm recall (2026-03-19), both citing endotoxin risks, as well as the AMD Medicom Ritmed Neurological Sponges Recall (2026-05-08) for endotoxin risk in surgery.

How to tell if you have this one

Check for the part number 801400 and lot number 6396457 on the packaging. The expiration date is June 30, 2027.

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

What to do — step by step

  1. Check Product Details

    Look for the part number 801400 and lot number 6396457 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 17 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: 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: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, Florida, Indiana, Kentucky, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, West Virginia.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Dec 2, 202212. FDA classified it Class II: Jan 6, 202323. Published in FDA’s Enforcement Report: Jan 18, 2023320222023
  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-0909-2023 (December 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0909-2023 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