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Open, Classified

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

FDA Recall Z-0147-2026 · Posted 2025-10-14

Recalling FirmEthicon Endo-Surgery Inc
Recall StatusOpen, Classified
Product CodeGDW
Date Initiated2025-09-11
Product Quantity3 units

Reason for Recall

The devices were shipped unsterilized.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the countries of United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223760ECHELON 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 · 2023-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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