Integra Codman ISOCOOL Bipolar Force: Tips May Not Coagulate Properly

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Contact the company & request your remedy

Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr, N/A · Plainsboro, NJ 08536-3344

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The forceps tips lack sufficient insulation coating, which may cause them to fail to coagulate tissue as intended during surgery. This could result in incomplete tissue sealing and potential bleeding. The hazard is specific to surgical use and does not affect normal consumer use.

Who’s affected

Surgical professionals using Codman ISOCOOL Bipolar Forceps model 8145100S for procedures like neurosurgery or ENT surgery. Patients undergoing these procedures are at risk if the forceps fail to coagulate tissue properly.

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

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

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The tips have inadequate insulation coating, which may cause the forceps to not coagulate tissue properly during surgery.

What procedures use these forceps?

These forceps are used in general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.

How can I tell if I have the recalled model?

The recalled model is 8145100S with lot number J2670Y.

Take action

Contact Integra

We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2206-2019 — Integra Integra

Hello,

I own a Integra that is covered by recall Z-2206-2019 from Integra.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Integra LifeSciences Corp. recalls Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during

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