Z-2399-2011

ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting...

Name: Z-2399-2011 ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting...
Creator: Encision, Inc.
Published: 2011-04-07
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2011-04-07 / Terminated / root cause: packaging

FDA source

Encision, Inc. began a recall of ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures on 2011-04-07. The reason FDA records is "Sterility may be compromised due to holes in packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2399-2011
Status: Terminated
Initiated: 2011-04-07
Posted: 2011-05-31
Terminated: 2011-08-09
Recalling firm: Encision, Inc.
Product: ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterility may be compromised due to holes in packaging.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.
Quantity in commerce: 44 Ten-Count Boxes
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand
Product codes and lots: Lot # QDI, QJJ, RAF

Product code GEI

K912780Class IIMonopolar Laparoscopic Electrodes W/eletroshieldElectroscope, Inc. / cleared 1991-12-30

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)