Ethicon ENSEAL G2 Tissue Sealers Recalled for Potential Self-Activation
Ethicon Endo-Surgery Inc. is recalling ENSEAL G2 Tissue Sealers because they may self-activate during use, causing unintended thermal damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of thermal injury to patients, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ethicon Endo-Surgery Inc. is recalling 58,338 ENSEAL G2 Tissue Sealers. These medical devices are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The recall covers specific model numbers including NSLG2C14, NSLG2C25, NSLG2C35, NSLG2C45, NSLG2514, NSLG2S25, NSLG2S35, and NSLGS545.
The recall was initiated because the devices have the potential for self-activation while in use. This malfunction may result in unintended thermal damage to tissue. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The affected instruments were distributed worldwide, including in the United States and numerous international countries. Healthcare providers and facilities should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. Users should stop using the affected devices and contact Ethicon Endo-Surgery Inc. for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 58,338
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code NSLG2C14
- Lot # H44Y2P
- Exp. Date 11-2013
- Lot # J4AR58
- Exp. Date 4-2017
- Lot # J4AT3V
- Lot # J4AW5A
- Exp. Date 5-2017
- Lot # J4AX7D
- Lot # J4C34A
- Exp. Date 6-2017
- Lot # J4C448
- Exp. Date 7-2017
- Lot # J4C449
- Lot # J4C85G
- Lot # J4CF5Z
- Exp. Date 9-2017 and Lot # J4CG31
- Exp. Date 9-2017. Product Code NSLG2C25
- Lot # H44Z6V
- Lot # J4A16C
Distribution
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