Coblator II System, 120V recallZ-1323-2015 · ArthroCare Medical Corporation · initiated Feb 20, 2015
Class II Terminated All recalls posted in March 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ArthroCare Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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).
FDA root cause category: Packaging process control
What the company is doing
ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3.
Recall details
- Recall number
- Z-1323-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 20, 2015
- Posted by the FDA
- Mar 26, 2015
- Recalling firm
- ArthroCare Medical Corporation
- Quantity
- 15 units
- Product code
- GEI
- FDA submissions
- K030108
- Distribution
- US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
Product description
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.
Code information (models, lots, serial numbers)
Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH
Other devices under the same FDA submission
3 devices cleared under K030108 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Coblation EC8000-01Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES39 reports
- COBLATION EC8001-01Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES22 reports
- COBLATOR II Controller 120V (SRVC controller-only) 13546-59Smith & Nephew, Inc. · Electrosurgical, cutting & coagulation & accessories3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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