Z-2097-2013Class II

E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to...

Name: Z-2097-2013 E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to...
Creator: Megadyne Medical Products, Inc.
Published: 2013-08-07
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2013-08-07 / Terminated / root cause: manufacturing process

FDA source

Megadyne Medical Products, Inc. began a recall of E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged... on 2013-08-07. FDA classified it as Class II and gives the reason as "Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation". 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-2097-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-07
Posted: 2013-08-27
Terminated: 2014-01-28
Recalling firm: Megadyne Medical Products, Inc
Product: E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Megadyne sent an Urgent: Medical Device Recall Field Safety Notice dated August 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were also notified with follow-up phone calls and email beginning on August 7, 2013. Customers were instructed to examine their stock immediately to determine if you have any of the products from the affected lots on hand. If so, please remove form service/discontinue use and contact Megadyne Customer Service at 1 (801) 576-9669 or (800) 747-6110 (USA) for return authorization and replacement or credit.
Quantity in commerce: 1816
Distribution: Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
Product codes and lots: Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2097-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2097-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code GEI

K913281Class IIE-Z Clean Laparoscopic ElectrodeMegadyne Medical Products, Inc. / cleared 1991-08-16

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)