Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue

The devices were shipped unsterilized.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0147-2026
• FDA 510(k) clearance · K223760The device's official FDA premarket clearance record
• FDA device classification · GDWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ethicon Endo-Surgery IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.