Z-1323-2015Class II

Coblator II System, 120V

Name: Z-1323-2015 Coblator II System, 120V
Creator: ArthroCare Medical Corporation
Published: 2015-02-20
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2015-02-20 / Terminated / root cause: packaging

FDA source

ArthroCare Medical Corporation began a recall of Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in... on 2015-02-20. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1323-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Posted: 2015-03-26
Terminated: 2016-02-26
Recalling firm: ArthroCare Corporation
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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).
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 15 units
Distribution: US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
Product codes and lots: Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1323-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

Product code GEI

K030108Class IIArthrocare ENT Coblator Surgery SystemArthrocare Corp. / cleared 2003-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)