Ethicon Endo-Surgery Inc — Class II medical device recall Z-0758-2013
Terminated recall by Ethicon Endo-Surgery Inc, reported 2013-02-06, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Potential for self activation while the device is in use, which may result in unintended thermal damage.
| Recall number | Z-0758-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Cincinnati, OH, United States |
| Recall initiated | 2012-11-06 |
| Classified | 2013-01-31 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2014-04-11 |
| Distributed | 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, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AU, BE, CA, CL, CN, CO, CY, HK, ID, IL, IN, KR, KW, MY, PA, PH, RU, SA, SG, SI, TH, TR, VN |
| Quantity | 58,338 instruments |
| Lot numbers | H44V7M, H44V7N, H44V7P, H44W25, H44W26, H44W27, H44X9L, H44X9M, H44X9R, H44Y2P, H44Y6N, H44Y8A, H44Y8K, H44Z3R, H44Z4C, H44Z54, H44Z57, H44Z5R, H44Z65, H44Z6J, H44Z6V, J4A085, J4A12R, J4A134, J4A164, J4A16C, J4A19D, J4AN7K, J4AN8D, J4AN8E, J4AP7W, J4AR58, J4AR5L, J4AR5P, J4AR6G, J4AR9C, J4AT05, J4AT1P, J4AT1U, J4AT22 and 188 more |
| Model numbers | NSLG2514, NSLG2C14, NSLG2C25, NSLG2C35, NSLG2C45, NSLG2S25, NSLG2S35, NSLGS545 |
| Expiration dates | 2013-10, 2013-11, 2013-12, 2017-04, 2017-05, 2017-06, 2017-07, 2017-08, 2017-09 |
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 for recall
Potential for self activation while the device is in use, which may result in unintended thermal damage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0758-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.