RecallRadar

FDA Device recall Z-0758-2013

Ethicon Endo-Surgery Inc

On 2013-02-06 the FDA classified a Class II recall of Ethicon Endo-Surgery Inc by Ethicon Endo Surgery, citing potential for self activation while the device is in use, which may result in unintended thermal damage.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0758-2013
ClassificationClass II
Statusterminated
Initiated2012-11-06
Published2013-02-06
Last updated2026-09-13 11:53 UTC
CompanyEthicon Endo Surgery
DistributionAK, 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, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV

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

Reason

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

Identifiers

code_info
Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017,…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0758-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.