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Lower risk Medical device recall · FDA · Published July 19, 2019

Integra Codman ISOCOOL Bipolar Force: Tips May Not Coagulate Properly

Integra recalls Codman ISOCOOL Bipolar Forceps model 8145100S with inadequate tip insulation that may cause improper tissue coagulation during surgery.

🇺🇸 FDA recall #Z-2206-2019Medical deviceIntegra ›
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Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr · Plainsboro, NJ 08536-3344
✎ GovInfoNow plain-language explainer

Integra is recalling Codman ISOCOOL Bipolar Forceps model 8145100S because the tips may not coagulate tissue properly during surgery. This could lead to incomplete tissue sealing and potential bleeding risks. The recall affects surgical instruments used in specific procedures like neurosurgery and ENT surgery. Read more at govinfonow.com/recall/67385-integra-codman-isocool-bipolar-force-tips-may-not-coagulate-properly.

Source Summary by GovInfoNow · govinfonow.com/recall/67385-integra-codman-isocool-bipolar-force-tips-may-not-coagulate-properly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2206-2019

Cite this page

“Integra Codman ISOCOOL Bipolar Force: Tips May Not Coagulate Properly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67385-integra-codman-isocool-bipolar-force-tips-may-not-coagulate-properly. Based on FDA recall #Z-2206-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2019%22&limit=1).

Integra LifeSciences Corp. recalled Codman ISOCOOL Bipolar Forceps on July 19, 2019, according to the FDA. The hazard is inadequate insulation coating that could prevent proper coagulation.

How to tell if you have it

  • Brand: Integra
  • Product: Codman ISOCOOL Bipolar Forceps
  • Model #: 8145100S
  • Lot #: J2670Y

The hazard

The tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since August 18, 2017. Recent similar recalls include the Integra AURORA Surgiscope System Recall (February 6, 2025), the MediHoney Wound Dressing Gel Recall (January 10, 2025), and the Integra LifeSciences CODMAN CERTAS Plus Valve Recall (December 16, 2024). Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), the Medline Forceps Recall (November 13, 2025), and the Codman CereLink ICP Sensor Basic Kit Recall (December 12, 2025).

How to tell if you have this one

Check for model number 8145100S on the forceps. The recall applies to instruments sold with lot number J2670Y.

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

What to do — step by step

  1. Check Model Number

    Verify the model number on the forceps; the recalled model is 8145100S.

Where it went and when

Where it was distributed

Distributed in 5 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: yesRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “KY,NJ, RI, TX, WA Foreign: BE” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Kentucky, New Jersey, Rhode Island, Texas, Washington.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Jul 19, 201912. FDA classified it Class II: Aug 7, 201923. Published in FDA’s Enforcement Report: Aug 14, 201934. FDA terminated the recall: May 22, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-2206-2019 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2206-2019 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