Ethicon Endo-Surgery Inc: ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Ethicon Endo-Surgery Inc
- Product
- ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- Reason / hazard
- The devices were shipped unsterilized.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- International distribution to the countries of United Arab Emirates.
- Recall initiated
- 2025-09-11
- Code info
- UDI-DI: 10705036030881; Lot Number: 904C12
- Product quantity
- 3 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Blue Ash
- State
- OH
- Country
- United States
- Event id
- 97654
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