Class II — Encision, Inc.
| Recalling firm | ENCISION, INC. |
|---|---|
| Registered facility | ENCISION, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures. |
| Product | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgi… |
| Quantity | 48 boxes |
| Distribution | Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand. |
| Initiated | 2012-06-15 |
| Classified | 2012-07-06 |
| Terminated | 2012-08-07 |
| Recall number | Z-1951-2012 |
| 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 — Encision, Inc. (Z-1951-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61529/
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