Device recall

Z-0758-2013: Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar…

FDA device recall · Class II · Ethicon Endo-Surgery Inc

Key facts

Recall number (Z-number) Z-0758-2013
Recall event 64055
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
Product code GEI
Recalling firm Ethicon Endo-Surgery Inc
Recall class Class II
Status Terminated
Termination date Apr 11, 2014
510(k) numbers K112033
FEI number 1527736

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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