Echelon Linear Cutter recallZ-0147-2026 · Ethicon Endo-Surgery Inc · initiated Sep 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon Endo-Surgery Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The devices were shipped unsterilized.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0147-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2025
- Posted by the FDA
- Oct 14, 2025
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 3 units
- Product code
- GDW
- FDA submissions
- K223760
- Distribution
- International distribution to the countries of United Arab Emirates.
Product description
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Code information (models, lots, serial numbers)
UDI-DI: 10705036030881; Lot Number: 904C12
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Echelon Linear Cutter GLC80Ethicon Endo-Surgery, LLC · Staple, implantable1 recall2 deaths113 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K223760 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Echelon Linear Cutter GLC100Ethicon Endo-Surgery, LLC · Stapler, surgical38 reports
- Echelon Linear Cutter GLC60Ethicon Endo-Surgery, LLC · Staple, implantable8 reports
- Echelon Linear Cutter GLCR80BEthicon Endo-Surgery, LLC · Staple, implantable5 reports
- Echelon Linear Cutter GLCR100BEthicon Endo-Surgery, LLC · Staple, implantable2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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