Coblator II System — Class II medical device recall Z-1323-2015
Terminated recall by ArthroCare Medical Corporation, reported 2015-04-01, distributed nationwide. The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 comp
| Recall number | Z-1323-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ArthroCare Medical Corporation, Austin, TX, United States |
| Recall initiated | 2015-02-20 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Serial numbers | CA0N0000FR, CA0N0000FT, CA0N0000FW, CA0N0000FZ, CA0N0000G5, CA0N0000G6, CA0N0000GH, CA0N0000H0, CA0N0000H1, CA0N0000H7, CA0N0000J6, CA0N0000KF, CA0N0000KJ, CA0N0000KK, CA0N0000KL |
| Model numbers | RF8000E |
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.
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).
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-1323-2015. 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.