FDAClass IIOctober 22, 2025

ECHELON LINEAR Cutters Reload 80 mm Blue recall

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Why was ECHELON LINEAR Cutters Reload 80 mm Blue recalled?

The devices were shipped unsterilized.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: 10705036030881; Lot Number: 904C12

Product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
3 units
Distribution
International distribution to the countries of United Arab Emirates.
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls