Z-0147-2026Class II

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of...

Name: Z-0147-2026 ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of...
Creator: Ethicon Endo-Surgery Inc
Published: 2025-09-11
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2025-09-11 / Open, Classified / root cause: sterility

FDA source

Ethicon Endo-Surgery Inc began a recall of ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 on 2025-09-11. FDA classified it as Class II and gives the reason as "The devices were shipped unsterilized". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0147-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-11
Posted: 2025-10-14
Recalling firm: Ethicon Endo-Surgery Inc
Product: ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Product code: GDW Staple, Implantable
Reason for recall: The devices were shipped unsterilized.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: An IMPORTANT CUSTOMER NOTIFICATION was sent to customers beginning 9/11/25. Actions Required Complete the Business Reply Form (BRF) (Attachment 1) confirming receipt and your understanding of this notification.
Quantity in commerce: 3 units
Distribution: International distribution to the countries of United Arab Emirates.
Product codes and lots: UDI-DI: 10705036030881; Lot Number: 904C12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0147-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0147-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14

Product code GDW

K223760Class IIECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)Ethicon Endo-Surgery / cleared 2023-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)