FDA Device recall Z-2206-2019
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neuros…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neuros… by Integra Lifesciences, citing tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2206-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences |
| Distribution | KY, NJ, RI, TX, WA |
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
Reason
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Identifiers
| code_info | Lot # J2670Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2019%22
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