Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing — Class II medical device recall Z-2206-2019
Terminated recall by Integra LifeSciences Corp., reported 2019-08-14, distributed in KY, NJ, RI, TX, WA. Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
| Recall number | Z-2206-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-08-07 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-05-22 |
| Distributed | KY, NJ, RI, TX, WA |
| Quantity | 125 units |
| Lot numbers | J2670Y |
| Model numbers | 8145100S |
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 for recall
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2206-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.