Recall archive / FDA device enforcement
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Produc... — FDA record Z-0147-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- Reason
- The devices were shipped unsterilized.
- Classification
- Class II
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 3 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0147-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10705036030881; Lot Number: 904C12 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of United Arab Emirates.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 22, 2025
- Recall initiation date
- Sep 11, 2025
- Center classification date
- Oct 14, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.