Z-1540-2010

AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision...

Name: Z-1540-2010 AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision...
Creator: Encision, Inc.
Published: 2010-04-05
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2010-04-05 / Terminated / root cause: manufacturing process

FDA source

Encision, Inc. began a recall of AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan... on 2010-04-05. The reason FDA records is "Electrosurgical electrode tip insulation may crack and break off during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1540-2010
Status: Terminated
Initiated: 2010-04-05
Posted: 2010-05-06
Terminated: 2010-05-21
Recalling firm: Encision, Inc.
Product: AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Electrosurgical electrode tip insulation may crack and break off during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.
Quantity in commerce: 20 units
Distribution: Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.
Product codes and lots: Lot No.: PK

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)