FDA Device recall Z-1951-2012
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories by Encision, citing 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 dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1951-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-15 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Encision |
| Distribution | CA, GA, NC, NY, OH, TX |
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 surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
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.
Identifiers
| code_info | RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1951-2012%22
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