—#216252

Product

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

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K223760
Affected lot / code info: UDI-DI: 10705036030881; Lot Number: 904C12

Why it was recalled

The devices were shipped unsterilized.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Blue Ash, Ohio 45242-2803

Distribution

Distribution pattern: International distribution to the countries of United Arab Emirates.

Timeline

Recall initiated: 2025-09-11
Posted by FDA: 2025-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.