FDAFDA · Food and drugs·Recall number Z-0147-2026
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Published October 22, 2025 · Recall initiated: September 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices were shipped unsterilized.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo-Surgery Inc
- Distributor
- International distribution to the countries of United Arab Emirates.
- Lot
- UDI-DI: 10705036030881; Lot Number: 904C12
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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