Class II — ConMed Corporation
| Recalling firm | CONMED CORPORATION |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. |
| Product | ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation. |
| Quantity | Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia. |
| Initiated | 2013-01-28 |
| Classified | 2013-02-15 |
| Terminated | 2017-04-11 |
| Recall number | Z-0826-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ConMed Corporation (Z-0826-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64248/
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