Z-0470-03

AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B

Name: Z-0470-03 AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
Creator: Encision, Inc.
Published: 2003-01-15
License: https://open.fda.gov/license/

Encision, Inc. / initiated 2003-01-15 / Terminated

FDA source

Encision, Inc. began a recall of AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B on 2003-01-15. The reason FDA records is "Reports of needle fixed-tip electrodes becoming loose or breaking off". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0470-03
Status: Terminated
Initiated: 2003-01-15
Posted: 2003-01-30
Terminated: 2003-04-14
Recalling firm: Encision, Inc.
Product: AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Reports of needle fixed-tip electrodes becoming loose or breaking off.
FDA root cause: Other
Action: All consignees will be notified by phone or visit beginning 01/15/2003.
Quantity in commerce: 58 devices.
Distribution: Domestic distribution to LA, MA, MN, OR, UT and WA.
Product codes and lots: Catalog # ES3521B. Lots FI, GC, GH, GL, HH, HI.

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)