Z-3097-2011

Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301

Name: Z-3097-2011 Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301
Creator: Encision, Inc.
Published: 2011-08-24
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2011-08-24 / Terminated / root cause: design

FDA source

Encision, Inc. began a recall of Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301 on 2011-08-24. The reason FDA records is "Electrode tips have been reported breaking off during use or cleaning". 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-3097-2011
Status: Terminated
Initiated: 2011-08-24
Posted: 2011-08-30
Terminated: 2012-09-04
Recalling firm: Encision, Inc.
Product: Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Electrode tips have been reported breaking off during use or cleaning.
Root cause tag: design
FDA root cause: Device Design
Action: Encision Inc. sent out an "Urgent Product Recall" letter dated August 24, 2011 to all affected customers. The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory. For information on this recall call Encision at (303) 339-6917.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
Product codes and lots: Catalog: REF ES3885. Lots: QI and RA.

Product code GEI

K100711Class IISuction Irrigation Electrodes and AdaptersEncision, Inc. / cleared 2010-06-09

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)