Ethicon Endo-Surgery Inc: Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545

Recall number

Z-0758-2013

Recalling firm

Ethicon Endo-Surgery Inc

Product

Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545

Status

Terminated

Initiated

2012-11-06

Posted

2013-01-31

Terminated

2014-04-11

Reason

Potential for self activation while the device is in use, which may result in unintended thermal damage.

Root cause

Process control

Action

Ethicon Endo-Surgery Inc. sent a "URGENT MEDICAL DEVICE RECALL" letter dated November 28, 2012, to all affected customers. The letter identified the the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1. Examine your inventory immediately to determine if you have affected product on hand and remove the affected product(s). 2. Complete the Business Reply Form and fax it to Stericycle at 1-877-787-0367 within 3 business days, even if you do not have affected product. Please reference Event 3436. If you have product to be returned, keep a copy of this form for your records. 3.To return affected product, photocopy your completed Business Reply Form, place it in the box with your product, and affix the pre-printed UPS shipping label to return to Stericycle. Note: Returned product will be credited. Should you have any questions, please contact your local representative or call our Customer Support Center, 1-800-873-3636, Option 6.

Quantity

58,338 Instruments

Distribution

Worldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.

Lot, serial or model codes

Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017.  Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017.  Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017, Lot # J4AX37, Exp. Date 5-2017, Lot # J4AX5Z, Exp. Date 5-2017, Lot # J4AX6E, Exp. Date 5-2017, Lot # J4AX8T, Exp. Date 5-2017, Lot # J4AX8U, Exp. Date 5-2017, Lot # J4AZ3P, Exp. Date 6-2017, Lot # J4AZ3V, Exp. Date 6-2017, Lot # J4AZ4W, Exp. Date 6-2017, Lot # J4AZ51, Exp. Date 6-2017, Lot # J4C11M, Exp. Date 6-2017, Lot # J4C11H, Exp. Date 6-2017, Lot # J4C15E, Exp. Date 6-2017, Lot # J4C17G, Exp. Date 6-2017, Lot # J4C174, Exp. Date 6-2017, Lot #, J4C187, Exp. Date 6-2017, Lot # J4C197, Exp. Date 6-2017, Lot # J4C17Y, Exp. Date 6-2017, Lot # J4C19M, Exp. Date 6-2017, Lot #, J4C225, Exp. Date 6-2017, Lot # J4C22H, Exp. Date 6-2017, Lot # J4C358, Exp. Date 6-2017, Lot # J4C35C, Exp. Date 6-2017, Lot # J4C36T, Exp. Date 6-2017, Lot # J4C427, Exp. Date 7-2017, Lot # J4C42D, Exp. Date 7-2017, Lot # J4C44P, Exp. Date 7-2017, Lot # J4C51U, Exp. Date 7-2017, Lot # J4C51W, Exp. Date 7-2017, Lot # J4C56E, Exp. Date 7-2017, Lot # J4C56A, Exp. Date 7-2017, Lot # J4C56Z, Exp. Date 7-2017, Lot # J4C56P, Exp. Date 7-2017, Lot # J4C58J, Exp. Date 7-2017, Lot # J4C58V, Exp. Date 7-2017, Lot # J4C65M, Exp. Date 7-2017, Lot # J4C66A, Exp. Date 7-2017, Lot # J4C66L, Exp. Date 7-2017, Lot # J4C758, Exp. Date 7-2017, Lot # J4C768, Exp. Date 7-2017, Lot # J4C85H, Exp. Date 7-2017, Lot # J4C85W, Exp. Date 7-2017, Lot # J4C906, Exp. Date 7-2017, Lot # J4C96P, Exp. Date 8-2017, Lot # J4C96Z, Exp. Date 8-2017, Lot # J4C879, Exp. Date 7-2017, Lot # J4CA4X, Exp. Date 8-2017, Lot # J4CA4Y, Exp. Date 8-2017, Lot # J4CC01, Exp. Date 8-2017, Lot # J4CC2G, Exp. Date 8-2017, Lot # J4CC4J, Exp. Date 8-2017, Lot # J4CD0C, Exp. Date 8-2017, Lot # J4CE10, Exp. Date 8-2017, Lot # J4CE16, Exp. Date 8-2017, Lot # J4CF0J, Exp. Date 8-2017, Lot # J4CF66, Exp. Date 9-2017, Lot # J4CJ0L, Exp. Date 9-2017, Lot # J4CJ5Z, Exp. Date 9-2017, Lot # J4CJ6J, Exp. Date 9-2017 and Lot # J4CK1K, Exp. Date 9-2017.  Product Code NSLG2C45, Lot # H44W26, Exp. Date 10-2013, Lot # H44W25, Exp. Date 10-2013, Lot # H44W27, Exp. Date 10-2013, Lot # J4A19D, Exp. Date 12-2013, Lot # J4AR6G, Exp. Date 4-2017, Lot # J4AU2R, Exp. Date 5-2017, Lot # J4AV5U, Exp. Date 5-2017, Lot # J4AZ53, Exp. Date 6-2017, Lot # J4C042, Exp. Date 6-2017, Lot # J4C122, Exp. Date 6-2017, Lot # J4C18F, Exp. Date 6-2017, Lot # J4C23J, Exp. Date 6-2017, Lot # J4C270, Exp. Date 6-2017, Lot # J4C32F, Exp. Date 6-2017, Lot # J4C62J, Exp. Date 7-2017, Lot # J4C62P, Exp. Date 7-2017, Lot # J4C816, Exp. Date 7-2017, Lot # J4C90E, Exp. Date 7-2017, Lot # J4C90F, Exp. Date 7-2017, Lot # J4C99K, Exp. Date 8-2017, Lot # J4CA8M, Exp. Date 8-2017, Lot # J4CD6Z, Exp. Date 8-2017, Lot # J4CJ73, Exp. Date 9-2017 and Lot # J4CK5E, Exp. Date 9-2017.  Product Code NSLG2S14, Lot # H44Z5R, Exp. Date 11-2013, Lot # J4C312, Exp. Date 6-2017, Lot # J4C639, Exp. Date 7-2017 and Lot # J4CG7Z, Exp. Date 9-2017.  Product Code NSLG2S25, Lot # H44Z57, Exp. Date 11-2013, Lot # J4AU2W, Exp. Date 5-2017, Lot # J4AW4P, Exp. Date 5-2017, Lot # J4AW4N, Exp. Date 5-2017, Lot # J4AX4W, Exp. Date 5-2017, Lot # J4AZ5M, Exp. Date 6-2017, Lot # J4C09V, Exp. Date 6-2017, Lot # J4C18R, Exp. Date 6-2017, Lot # J4C22J, Exp. Date 6-2017, Lot # J4C27C, Exp. Date 6-2017, Lot # J4C34E, Exp. Date 6-2017, Lot # J4C34F, Exp. Date 6-2017, Lot # J4C34K, Exp. Date 6-2017, Lot # J4C37R, Exp. Date 6-2017, Lot # J4C49E, Exp. Date 7-2017, Lot # J4C49G, Exp. Date 7-2017, Lot # J4C576, Exp. Date 7-2017, Lot # J4C577, Exp. Date 7-2017, Lot # J4C63W, Exp. Date 7-2017, Lot # J4C67U, Exp. Date 7-2017, Lot # J4C75N, Exp. Date 7-2017, Lot # J4C75X, Exp. Date 7-2017 and Lot # J4C92G, Exp. Date 7-2017.  Product Code NSLG2S35, Lot # H44Y6N, Exp. Date 11-2013, Lot # H44Y8A, Exp. Date 11-2013, Lot # H44Y8K, Exp. Date 11-2013, Lot # H44Z65, Exp. Date 11-2013, Lot # H44Z6J, Exp. Date 11-2013, Lot # J4A164, Exp. Date 12-2013, Lot # J4AR9C, Exp. Date 4-2017, Lot # J4AT1U, Exp. Date 4-2017, Lot # J4AT22, Exp. Date 4-2017, Lot # J4AT4H, Exp. Date 4-2017, Lot # J4AU2X, Exp. Date 5-2017, Lot # J4AW31, Exp. Date 5-2017, Lot # J4AW36, Exp. Date 5-2017, Lot # J4AW9D, Exp. Date, 5-2017, Lot # J4AW9H, Exp. Date, 5-2017, Lot # J4AX62, Exp. Date, 5-2017, Lot # J4AX8Y, Exp. Date, 5-2017, Lot # J4AX9F, Exp. Date, 5-2017, Lot # J4C100, Exp. Date, 6-2017, Lot # J4C109, Exp. Date, 6-2017, Lot # J4C15H, Exp. Date, 6-2017, Lot # J4C18W, Exp. Date, 6-2017, Lot # J4C209, Exp. Date, 6-2017, Lot # J4C20A, Exp. Date, 6-2017, Lot # J4C23K, Exp. Date, 6-2017, Lot # J4C27E, Exp. Date, 6-2017, Lot # J4C27H, Exp. Date, 6-2017, Lot # J4C32G, Exp. Date, 6-2017, Lot # J4C34M, Exp. Date, 6-2017, Lot # J4C435, Exp. Date, 7-2017, Lot # J4C43J, Exp. Date, 7-2017, Lot # J4C537, Exp. Date, 7-2017, Lot # J4C53G Exp. Date, 7-2017, Lot # J4C53T, Exp. Date, 7-2017, Lot # J4C57N, Exp. Date, 7-2017, Lot # J4C57P, Exp. Date, 7-2017, Lot # J4C64N, Exp. Date, 7-2017, Lot # J4C64U, Exp. Date, 7-2017, Lot # J4C73T, Exp. Date, 7-2017, Lot # J4C73X, Exp. Date, 7-2017, Lot # J4C914, Exp. Date, 7-2017, Lot # J4C90W, Exp. Date, 7-2017, Lot # J4C92Z, Exp. Date, 7-2017, Lot # J4CE93, Exp. Date, 8-2017 and Lot # J4CC02, Exp. Date, 8-2017.  Product Code NSLG2S45, Lot # J4A12R, Exp. Date 12-2013, Lot # J4AV6G, Exp. Date 5-2017, Lot # J4AV6T, Exp. Date 5-2017, Lot # J4AX9V, Exp. Date 5-2017, Lot # J4C15V, Exp. Date 6-2017, Lot # J4C30V, Exp. Date 6-2017, Lot # J4C37T, Exp. Date 6-2017, Lot # J4C67E, Exp. Date 7-2017, Lot # J4C67J, Exp. Date 7-2017, Lot # J4C67M, Exp. Date 7-2017, Lot # J4C74T, Exp. Date 7-2017 and Lot # J4CC9G, Exp. Date 8-2017.

510(k) numbers

["K112033"]

PMA numbers

not on file

Product code

GEI

Firm FEI

1527736

Firm city

Cincinnati

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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