Z-1132-04

Encision ES4107 Disposable AEM Cord, Sterile

Name: Z-1132-04 Encision ES4107 Disposable AEM Cord, Sterile
Creator: Encision, Inc.
Published: 2004-07-09
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2004-07-09 / Terminated / root cause: packaging

FDA source

Encision, Inc. began a recall of Encision ES4107 Disposable AEM Cord, Sterile on 2004-07-09. The reason FDA records is "Firm found pinholes in packaging which would compromise sterility". 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-1132-04
Status: Terminated
Initiated: 2004-07-09
Posted: 2004-07-22
Terminated: 2004-12-14
Recalling firm: Encision, Inc.
Product: Encision ES4107 Disposable AEM Cord, Sterile.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Firm found pinholes in packaging which would compromise sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Affected customers were notified by fax or mail on 7/15/2004.
Quantity in commerce: 73 units
Distribution: AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
Product codes and lots: REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.

Product code GEI

K913625Class IIElectroscope Monitor, Em-1Electroscope, 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)