FDAJuly 19, 2019device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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