Ethicon Endo-Surgery recalled 3 ECHELON Linear Cutter Reload 80 mm Blue devices, Product Number GLC80, distributed internationally to the United Arab Emirates, after they were shipped unsterilized. The devices were shipped unsterilized, creating a potential infection risk. Healthcare providers should stop using the device immediately and await instructions from Ethicon Endo-Surgery.
The devices were shipped unsterilized.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ethicon Endo-Surgery Inc or your healthcare provider for instructions. Notification method: Letter
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The ECHELON Linear Cutter Reload is used in surgical procedures to transect, resect, and create anastomoses during minimally invasive surgery.
Unsterilized devices pose a potential infection or contamination risk to patients during procedures.
This recall is not indicated as part of a broader industry pattern.
Affecting 3 units distributed internationally to UAE. No injuries reported yet. Potential risk during surgical procedures if unsterilized devices are used.
Serials, UDI, and lot numbers are on device packaging and labeling. FDA recall page linked in the notice.
Remedy and replacement timelines typically 4-8 weeks for processing.
Keep copies of recall letters, packaging, and correspondence; photograph packaging and labeling for records.
ECHELON LINEAR Cutters Reload 80 mm Blue, Product Number GLC80. Manufacturer: Ethicon Endo-Surgery. Recall date: 2025-09-11. Distribution: International, UAE. Quantity: 3 units. UDI-DI: 10705036030881. Lot Number: 904C12.
No injuries or incidents have been reported.
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