ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product N
Summary
The FDA issued a Class II for ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, a by Ethicon Endo-Surgery Inc. Reason: The devices were shipped unsterilized..
Details
Source
Device Recall
External ID
Z-0147-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Lot/Code Info: UDI-DI: 10705036030881; Lot Number: 904C12
Quantity Affected: 3 units
Reason for Recall
The devices were shipped unsterilized.
Distribution
International distribution to the countries of United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-11
Company
Blue Ash, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon Endo-Surgery Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon Endo-Surgery Inc have FDA actions?
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0147-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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