Encision, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1951-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 15, 2012

Date Posted: July 18, 2012

Recall Number: Z-1951-2012

Event ID: 61529

Reason for Recall:

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.

Status: Terminated

Product Quantity: 48 boxes

Code Information:

RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.

Distribution Pattern:

Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.

Voluntary or Mandated:

Voluntary: Firm initiated