FDAClass IIJuly 3, 2019

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft recall

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C

Why was Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft recalled?

Observed reported incidence rate for harm associated with intraoperative bleeding

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot numbers

Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
308 boxes
Distribution
Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Recall date
July 3, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls