Z-2206-2019Class II

Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue...

Name: Z-2206-2019 Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue...
Creator: Integra LifeSciences Corp.
Published: 2019-07-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2019-07-19 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery... on 2019-07-19. FDA classified it as Class II and gives the reason as "Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2206-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-08-07
Terminated: 2020-05-22
Recalling firm: Integra LifeSciences Corporation
Product: Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
FDA root cause: Under Investigation by firm
Action: Integra LifeSciences issued recall letter on July 19, 2019 advising of problem, health risk and action to take: 1.Review your inventory and determine if you have any impacted lot. 2. If you do have product with an affected Lot Number, stop using the product immediately and remove the product from service. 3. Complete the attached form. If you do not have affected product, check the box, I do not have any product with the lot number. 4. If you do have affected product, check the box I do have product{s) with the lot number. Record the total quantity of affected product you have. 5. Complete the other information and Return the completed "Acknowledgement and Return Form" by email or fax indicating your receipt and review of this notification. Keep a copy of the form for your records. Customer Service will contact you and provide an RMA number and directions to return the product. A replacement order will also be placed for the quantity noted on the form. Customer Service Monday to Friday 8:00 AM - 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401
Quantity in commerce: 125 units
Distribution: KY,NJ, RI, TX, WA Foreign: BE
Product codes and lots: Lot # J2670Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2206-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2206-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07

Product code GEI

K083895Class IICodman Isocool Bipolar ForcepsCodman & Shurtleff, Inc. / cleared 2009-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)