Z-1074-04

AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable

Name: Z-1074-04 AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable
Creator: Encision, Inc.
Published: 2004-06-11
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2004-06-11 / Terminated

FDA source

Encision, Inc. began a recall of AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable on 2004-06-11. The reason FDA records is "Electrosurgical tip may break or come off during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1074-04
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-09-22
Terminated: 2004-11-09
Recalling firm: Encision, Inc.
Product: AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Electrosurgical tip may break or come off during use.
FDA root cause: Other
Action: Customers were notified beginning 6/15/2004 by phone or visit.
Quantity in commerce: 335 units
Distribution: AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
Product codes and lots: Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.

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)