Integra LifeSciences Corp. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
Lot # J2670Y
Products Sold
Lot # J2670Y
Integra LifeSciences Corp. is recalling Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulatin due to Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Recommended Action
Per FDA guidance
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: custsvcnj@integralife.com Outside USA: 781-565-1401
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
KY, NJ, RI, TX, WA
Page updated: Jan 10, 2026