Z-1247-2012

ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon...

Name: Z-1247-2012 ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon...
Creator: Ethicon Endo-Surgery Inc
Published: 2012-01-26
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2012-01-26 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 The... on 2012-01-26. The reason FDA records is "Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i)...". 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-1247-2012
Status: Terminated
Initiated: 2012-01-26
Posted: 2012-03-21
Terminated: 2013-02-15
Recalling firm: Ethicon Endo-Surgery Inc
Product: ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ethicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to: Ethicon Endo-Surgery ATT: ENSEAL G2 Recall 4545 Greek Road Cincinnati, Ohio 45242 Customers were instructed to choose one of the following response options: Return the Business Reply Form to their sales representative Call 1-800-873-3636, Option 6 Fax the BRF to 1-513-337-4138 For any questions regarding this recall call 513-337-3419.
Quantity in commerce: 246 pieces
Distribution: Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
Product codes and lots: Product Code 00NSLG2S35, Lot #, H44Y6N, Exp Date, Nov-2013, Lot # H44Y8A, Exp Date, Nov-2013, Lot # H44Y8K, Exp Date, Nov-2013, Lot # H44Z65, Exp Date, Nov-2013, Lot # H44Z6J, Exp Date, Nov-2013 & Lot # J4A164, Exp Date, Dec-2013.

Product code LFL

K112033Class IIEnseal G2 Tissus SealersEthicon Endo-Sugery, LLC / cleared 2011-11-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)