Z-1951-2012Class II

AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable...

Name: Z-1951-2012 AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable...
Creator: Encision, Inc.
Published: 2012-06-15
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2012-06-15 / Terminated / root cause: design

FDA source

Encision, Inc. began a recall of AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories... on 2012-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1951-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Posted: 2012-07-06
Terminated: 2012-08-07
Recalling firm: Encision, Inc.
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: design
FDA root cause: Device Design
Action: Encision sent an Urgent Medical Device Recall letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to lubricate the contact on the instrument cord with a conductive gel (to be supplied by Encision) prior to making the connection of the cord to the instrument. Instructions for applying the gel were attached. This corrective action was temporary; allowing customers to use their inventory of devices and for new product in the short term, until a design correction can resolve the problem. Customers would be contacted by their Encision Sales Representative to review this information for their specific situation and train their staff on its correction. For questions customers should call 303-339-6917 or Customer Service at 800-998-0986. For questions regarding this recall call 303-339-6917.
Quantity in commerce: 48 boxes
Distribution: Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
Product codes and lots: RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1951-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1951-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code GEI

K091074Class IIAem Disposable Electrodes,model Eso300 SeriesEncision, Inc. / cleared 2009-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)