Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coblator II System Recalled by ArthroCare Medical Corporation Due to The recalling firm was notified by the contract...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ArthroCare Medical Corporation directly.
Affected Products
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
Quantity: 15 units
Why Was This Recalled?
The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ArthroCare Medical Corporation
ArthroCare Medical Corporation has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report